MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC JAUNDICE - JM103/105; BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM

Model Number	MU20105
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Jaundice (2187)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has started.A follow up report will be submitted upon completion.
Event or Problem Description
It was reported a blood sample was taken from a baby at 8 days of age, for non-weight gain; the baby was potentially outgoing.His transcutaneous bilirubin was measured at 252 micromoi/l (outside the phototherapy curve).At the time of the check-up, his plasma bilirubin measurement = 352 micromoi/l, which equals indication for phototherapy treatment.The baby received 3 sessions of 3h00 of phototherapy.Readings of the jaundice meter that are outside specification in the lower direction may not be obvious to the user and may not prompt a blood test for verification which could lead to a delay in required treatment.In this case there was no adverse patient impact.
Additional Manufacturer Narrative
Additional information was provided by the customer that the jm105 reading was misinterpreted by the midwife who sent a report to the french competent authority.The department's pediatrician confirmed there no device error and there was no reason for a report to have been sent.The patient received appropriate treatment.On (b)(6) 2024 draeger met with the customer and went over the correct protocol for using the jm105 for data collection.The customer was advised to measure the transcutaneous bilirubin levels on babies for whom a blood bilirubin analysis was planned, and they were told to plot both values in the provided data sheet.They were reminded that the time between sampling and measurement of transcutaneous bilirubin should not exceed one hour and a series of ten measurements is sufficient for seeing a correlation between transcutaneous and blood values.In conclusion, this complaint was opened due to the customer's misinterpretation of the device reading.
Event or Problem Description
It was reported a blood sample was taken from a baby at 8 days of age, for non-weight gain; the baby was potentially outgoing.His transcutaneous bilirubin was measured at 252 micromoi/l (outside the phototherapy curve).At the time of the check-up, his plasma bilirubin measurement = 352 micromoi/l, which equals indication for phototherapy treatment.The baby received 3 sessions of 3h00 of phototherapy.Readings of the jaundice meter that are outside specification in the lower direction may not be obvious to the user and may not prompt a blood test for verification which could lead to a delay in required treatment.In this case there was no adverse patient impact.

• Brand Name: JAUNDICE - JM103/105
• Common Device Name: BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 9784097390
• MDR Report Key: 21540558
• Report Number: 1220063-2025-00018
• Device Sequence Number: 12775113
• Product Code: MQM
• UDI-Device Identifier: 04049098000246
• UDI-Public: (01)04049098000246(11)230817(93)MU20105-24
• Combination Product (Y/N): N
• PMA/510(K) Number: K133175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MU20105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown