MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. JAUNDICE JM105; JAUNDICE METER/BILIRUBINOMETER

Catalog Number	MU20105
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	Jaundice (2187); Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the jaundice meter (jm) 105 gave "mostly" low readings.No adverse patient impact or patient death was reported.
Event or Problem Description
The customer reported that the jaundice meter (jm) 105 gave "mostly" low readings.No adverse patient impact or patient death was reported.
Additional Manufacturer Narrative
A complaint was received regarding a jm105 with lower readings than the total serum bilirubin (tsb).No adverse patient impact was reported.The customer provided patient jaundice meter readings and blood readings comparison data along with answers to the jm105 clinical questions.An analysis of the data showed out of the 23 eligible checks, 8 were found to be within the draeger standard deviation of plus or minus 1.5 as outlined in the instructions for use (ifu).The ifu further states that based on the average of clinical data available, 66% of the values taken with the jm105 should fall within the standard deviation range.The eligible readings that were provided would indicate a 32% pass rate however, some of the clinical data such as hours of life and skin type of some of the patients was missing.In addition, several requests were made to determine if the customer was processing the tsb in the lab within the 1hour timeframe, but this information was not made available.The device was sent to telford.

• Brand Name: JAUNDICE JM105
• 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 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 9784828529
• MDR Report Key: 20246056
• Report Number: 2510954-2024-00039
• Device Sequence Number: 7282713
• Product Code: MQM
• UDI-Device Identifier: 04049098000246
• UDI-Public: (01)04049098000246(11)240228(93)MU20105-25
• 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: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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 Catalogue 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: 08/20/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• 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