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

Catalog Number	MU20105
Medical Device Problem Codes	Low Readings (2460); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Jaundice (2187)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a jaundice meter reads outside of the tolerance 1.5, + or - at least 66% of the time when compared to serum bilirubin.There was no report of a patient injury or death.
Additional Manufacturer Narrative
It was reported to drager that the jm105 jaundice meter was providing inconsistent readings outside of the 1.5 standard deviation when compared to tsb values.The customer provided a data sheet and the answers to the clinical questions however, when their data was analyzed, it was found that only 17 checks were eligible readings having had the blood processed within the 1-hour time frame.Out of the 16 eligible checks, 10 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 fall within the standard deviation range.According to the data provided by the customer, their data showed this unit to have given values within range 62.5% of the time, the greater deviation could be due to the timeframe of when the blood was processed being closer to the 1hr mark.The meter was analyzed by draeger and during the pre-calibration inspection of the device the engineer discovered that the values were within range and passed the checker test however, the short-wave value (.57) was closer to the low side when compared to the tolerances given on the base (the range for the short-wave acceptable value was -2.3 to.3).This device was last calibrated on 09nov2023, but the engineer recommended another calibration.The device was calibrated to satisfactory standards with the values falling within the tolerance ranges.The root cause of the inconsistent readings the customer is reporting could not be determined as there was no mention of device damage by the engineer and no functional problems with the device.The device was returned to the customer.No further issues have been reported.
Event or Problem Description
The customer reported that a jaundice meter reads outside of the tolerance 1.5, + or - at least 66% of the time when compared to serum bilirubin.There was no report of a patient injury or death.

• 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 ; 2156602400
• MDR Report Key: 19580587
• Report Number: 2510954-2024-00030
• Device Sequence Number: 7326274
• Product Code: MQM
• UDI-Device Identifier: 04049098000246
• UDI-Public: (01)04049098000246(11)240201(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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown