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	Jaundice (2187)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer has consistently noted a difference in a jm-105 jaundice meters readings of 6 to 7mg/dl lower from serum on two different laboratory devices.No adverse patient impact was reported.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Additional Manufacturer Narrative
The customer provided patient tcb and tsb reading comparison data used to determine the differences in tcb and tsb readings for analysis.However, as the data provided does not include the age of the babies or the time that the blood was drawn, it cannot be analyzed.The customer was asked to repeat the measurements using the provided data collection sheet (which includes fields for the data needed for comparison analysis).No further information was provided by the customer.As per the instructions for use, the age population for the device to be used on is >= 35 weeks gestation up 14 days old.Additionally, the time of the blood test to compare to the meter reading must be documented and taken within an hour of the meter reading for a comparison to be made.Therefore, the reported reading differences could not be verified.The involved meter was return to draeger for investigation and has been evaluated by draeger engineering.The meter was tested on the light checker and the measurements were within specification.Therefore, the root cause of the reported issue cannot be determined.Though no malfunction was identified, the meter was recalibrated for customer satisfaction and returned to the customer through the draeger medical repair center.
Event or Problem Description
It was reported that the customer has consistently noted a difference in a jm-105 jaundice meters readings of 6 to 7mg/dl lower from serum on two different laboratory devices.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
• MDR Report Key: 16935838
• Report Number: 2510954-2023-00005
• Device Sequence Number: 5730921
• Product Code: MQM
• UDI-Device Identifier: 04049098000246
• UDI-Public: (01)04049098000246(11)230102(93)MU20105-24
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/23/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• 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