Page 1 JAUNDICE METER JAUNDICE METER JM-103 JM-103 Captures Data Instantly, Compact, Easy to Operate, Designed for All Skin Colors Captures Data Instantly, Compact, Easy to Operate, Designed for All Skin Colors Actual Size Direct reading for total serum bilirubin in mg/dL or micro mol/L Premature baby measurable (more than 1000g) Skin color affects measurment much less than in previous models. Page 2 - 2 Jaundice Meter Instructions for Use (MU01380) Phototherapy WARNING: Do not use the Jaundice Meter after initiation of phototherapy or after an exchange transfusion. Results may be inaccurate under these conditions. Explanation of the Test Measuring Principle The Jaundice Meter determines the yellowness of an infant’s.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death
Recalled Product:
- Name: Jaundice Meter JM-103 and Jaundice Meter JM-105
- Product code: MQM
- Model numbers: JM-103: MU20606; JM-105: MU20105
- Manufacturing Dates: JM-103 June 2008 to August 2017, JM-105 September 2013 to April 2018
- Distribution Dates: JM-103 July 2008 to September 2017, JM-105 October 2013 to April 2018
- Devices Recalled in the U.S.: JM-103: 2449; JM-105: 2063
Device Use
The JM-103 and JM-105 Jaundice Meters are non-invasive transcutaneous bilirubinometers, which measure yellowness of subcutaneous tissue in newborn infants. The unit provides a visual digital measurement that has been shown to correlate with blood levels of bilirubin in newborn infants. High levels of bilirubin (hyperbilirubinemia) may indicate jaundice or other conditions which require medical attention.
The device is intended for use in hospitals or doctors' offices under a physician's supervision or at their direction to assist clinicians in monitoring newborn infants. The device is not intended as a standalone screening device for diagnosis of hyperbilirubinemia. It is used as a screening device along with other clinical assessments and laboratory measurements.
The JM-105 is a modification of the JM-103 jaundice meter. The basic functionality, including the measuring probe, hardware, and software used to process the measurements, are identical to the JM-103. The display of the JM-105 includes a larger screen and touchscreen, and data storage and transmission functionality.
Jm 103 Jaundice Meter Price
Reason for Recall
Draeger Medical Systems, Inc. is recalling their Jaundice Meter JM-103 and JM-105 models which are used to measure bilirubin in newborn infants. The meters are being recalled because users have misinterpreted display messages that have resulted in serious injuries. Specifically, the JM-103 Meter displays three blinking dashes (- - -) and the JM-105 Meter displays dash-zero-dash (-0-) when the bilirubin level in the patient is higher than the maximum level of detection (>340µmol or 20mg/dl). Measurement of high bilirubin indicates a need for immediate medical evaluation. Some users have interpreted the two display messages as indicating a 'low' or 'zero' value instead of high bilirubin levels. When this happens, treatment may be delayed or not offered, which could lead to brain damage and possibly death in some newborns/infants.
The out of range display is visible; however, the interpretation of the reading is not intuitive or clear. Uncertainty about the out of range indication on the Jaundice meter could cause a delay of treatment in a patient with hyperbilirubinemia.
The misuse of display information could increase risk for serious adverse health consequences such as acute and/or chronic brain damage or death.
Who May be Affected
Newborn infants who are being monitored by a physician for hyperbilirubinemia.
What to Do
Draeger Medical issued an Urgent Medical Device Safety Notice to customers with the following instructions:
- Ensure that all JM-105 and JM-103 devices are labeled per the instructions provided by the firm in a timely manner. Draeger provided their users with labels which should be applied directly onto the meter to remind the user of the meaning of the blinking (---) for the JM-103 model, and (-0- ) for the JM-105 model. The label has a picture of the out of range display messages as they appear on the meter with three blinking (---) for JM-103 or (-0-) for JM-105: and the interpretation of the messages stating 'Measurement out of range >340µmol/L/20mg/dL.'
- Provide training to all users in the clinical environment on how to use the equipment, and ensure that they understand that this is a screening device not to be used as a standalone diagnostic device.
- Perform a blood test if they obtain a bilirubin measurement that is above the device maximum value of 20mg/dL or 340µmol.
- Complete and return the Customer Reply card sent by the firm.
- Look for a separate communication letter from Draeger which notifies those using JM-105 about the availability of upgraded software and provides instructions for sending the device to the firm if they choose to have the upgrade implemented.
Contact Information
Draeger Medical Systems, Inc.
3135 Quarry Road, Telford Pennsylvania
USA 18969-1042
Full List of Affected Devices
Date Recall Initiated
May 21, 2018
Additional Resources
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.
Regulated Product(s)
Topic(s)
Jm 103 Jaundice Meter Manual Instructions
A simple, effective, portable non-invasive jaundice meter
The transcutaneous jaundice meter from Delta Medical International offers a reliable, non-invasive method for screening babies for jaundice. The product is convenient, effective and proven, reducing the need for blood sampling and thus contributing to developmental care practice.
Clinical Background
Neonatal jaundice occurs frequently in newborn babies1 and has long been a concern for healthcare professionals. If left untreated it can have severe consequences for the child, so early detection is vital.
The use of visual inspection alone is widely considered unacceptable as it can lead to false estimates2, with babies then being put at risk of hyperbilirubinemia due to under-estimation. Equally visual examination may also lead to over-estimation of babies at risk, resulting in unnecessary invasive blood testing of total serum bilirubin (TsB).
It is recognised that the bilirubin levels of newborn infants often peak two to four days after delivery, after most term babies have gone home3 and can lead to them needing to be readmitted to hospital for treatment. Screening using a non-invasive measurement can thus offer a simple and convenient way to avoid later complications.
Once diagnosed jaundice can often be simply treated by using a phototherapy system to break down excess bilirubin levels.
Transcutaneous Bilirubin Measurement
It is well established that the transcutaneous measurement of bilirubin level is well correlated with serum concentration2,3,4. The advantages to the healthcare professional and the patient of being able to determine bilirubin levels instantly and non-invasively are obvious.
Portable transcutaneous jaundice meters offer a quick and easy method for dynamic and ongoing assessment to identify abnormal bilirubin levels. They are suitable for use in all clinical settings: NICU; SCBU; maternity; post-natal; and in the community.
Developmental Care Considerations
It is well documented that neonates undergo numerous invasive procedures on a daily basis5; this not only causes unnecessary stress on the infant, but can also impact their long-term developmental care outcome. Using a transcutaneous jaundice meter dramatically reduces the need to take blood samples for hyperbilirubinemia testing; no painful needles is much kinder to babies.
The simplicity of operation and speed of obtaining readings with the jaundice meter that Delta Medical supply makes repeated testing to measure efficacy of treatment possible, with minimal impact on the patient. It is therefore practical to determine whether further intervention needs to be considered and to optimise patient care whilst following best developmental care principles. The reduction in neonatal stress and parental anxiety add to the process of optimising developmental care.
Product Features & Benefits
MBJ20 jaundice meter is very simple to apply and operate, making it very quick and easy to obtain bilirubin readings with minimal disturbance to the baby. The compact ergonomic design makes it easy to hold, with a display that is easy to read, and very convenient to carry around. It is suitable for screening infants from 35 weeks’ gestation and automatically stores the last 20 readings for review if needed.
The advanced optical design and processing algorithms ensure highest accuracy. Self-calibration ensures accuracy and efficacy; the unit is supplied with an external calibration unit for periodic checks and adjustment; there is negligible maintenance required.
The unit is easily cleaned for infection control. The reduction in need for blood sampling gives further potential advantages in relation to infection prevention in addition to the developmental care considerations.
The portability and simplicity make the unit ideal for use in all areas, including routine post-natal care and community care. The jaundice meter can facilitate routine screening and accelerate appropriate care and treatment of babies who may have an elevated bilirubin level.
Product Specifications
References
- National Institute for Health & Care Excellence (NICE). Clinical Guidance CG98: Jaundice in newborn babies under 28 days. www.nice.org.uk, 2010
- American Academy of Pediatrics Subcommittee of hyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics, 2004
- Holland, L., & Blick, K. Implementing and validating transcutaneous bilirubinometry for neonates. AJCP, 2009.
- Najundaswamy, S, Petrova, A., et al. The accuracy of transcutaneous bilirubin measurements in neonates: a correlation study. Neonate, 2004
- Carbajal, R., Rousset, A., Danan, C., et al. Epidemiology and treatment of painful procedures in neonates in intensive care units. JAMA, 2008
Brochure Download
Click to download the Jaundice Meter product brochure
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