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.
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 device was sent to telford for analysis and according to service note order (b)(4) the meter passed the pre-inspection test, and the test checker readings were within tolerance.The engineer recalibrated the device for customer satisfaction and all the functions of the jm105 passed post calibration, and the device was sent back to the customer.The customer provided patient jaundice meter readings and blood readings comparison data along with answers to the jm105 clinical questions.Based on the information given by the user, criteria for proper use of the jm105 and for processing the blood for tsb measurements were being met.An analysis of the data provided did not result in a precise root cause explaining the values that were not within the 1.5 deviation, which drager has determined through clinical trials to be acceptable deviations.Because there was no malfunction found with the device and additional training with the use of the jaundice meter does not appear to be needed at this time, an exact root cause cannot be determined.No further issues have been reported with this device.According to the instructions for use (ifu) the jm105 jaundice meter is to be used a screening device in conjunction with other clinical signs and laboratory measurements prior to making treatment decisions.
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.

• 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: 20247746
• Report Number: 2510954-2024-00042
• Device Sequence Number: 15276731
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown