MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC JM-105 JAUNDICE METER; JAUNDICE METER/BILIRUBINOMETER

Model Number	MU20105
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Event or Problem Description
It was reported that the jm105 jaundice meter was measuring incorrectly, the reading were lower than expected.No adverse patient impact was reported.
Additional Manufacturer Narrative
Interviews with the customer revealed that the expressed concern was related to the aspect that the readings of the jm-105 transcutaneous bilirubin (tcb) were almost 3 points lower than the total serum bilirubin (tsb) blood test results.The involved dräger device was subject to an in-depth evaluation whereby no deviations from specification could be found.Before the device was returned to the customer, a preventive maintenance was performed.In particular, the battery was replaced, an upgrade to the firmware was made and a recalibration was performed.Dräger came to the conclusion that the reported issue must be attributed to application aspects.Dräger recommends that - if the measurement with the jm-105 indicate the necessity of a blood gas analysis, the latter shall be performed within 60 minutes of time.It could be revealed that the lab testing at the user facility takes at an average 2 to 4 hours until results are available.It was concluded that this delay was the major factor for the divergence between the values of both measurement methods.Additionally, it could be revealed that even the jm-105 readings with the biggest divergence to the tsb results are still in the range to trigger the adequate clinical decision.
Event or Problem Description
It was reported that the jm105 jaundice meter was measuring incorrectly, the reading were lower than expected.No adverse patient impact was reported.

• Brand Name: JM-105 JAUNDICE METER
• Common Device Name: JAUNDICE METER/BILIRUBINOMETER
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 9783798000
• MDR Report Key: 17332528
• Report Number: 2510954-2023-00011
• Device Sequence Number: 7361617
• Product Code: MQM
• UDI-Device Identifier: 04049098000246
• UDI-Public: (01)04049098000246(11)190621(93)MU20105-18
• Combination Product (Y/N): N
• PMA/510(K) Number: K133175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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