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 Code	Jaundice (2187)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the jm-105 provided low values.No adverse patient impact was reported.
Additional Manufacturer Narrative
The investigation was started; results will be provided in a follow up-report.
Additional Manufacturer Narrative
It was reported to draeger that the jm105 was readings lower than the total serum bilirubin (tsb).The jm105 was returned to draeger for evaluation.The draeger technician found the jaunice meter was performing within the acceptable range prior to a recalibration.The draeger technician did notice a low battery icon after charging the device and then checking the values against the base.According to the ifu, a low battery would have a low battery indicator that would be obvious to the user and a battery malfunction would show an error05 and the device should be removed from service.The draeger technician replaced the battery and although no malfunction with meter readings was identified, the meter was recalibrated for customer satisfaction and was returned 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.The product manager has recommended an on-site evaluation to observe and determine if there is a user influence on the readings that are being obtained and has asked marketing and sales to reach out to the customer.No further issues have been reported with this device.If further information becomes available to help determine root cause, this complaint will be reopened for proper documentation.
Event or Problem Description
It was reported that the jm105 provided low values.No adverse patient impact was reported.

• Brand Name: JAUNDICE JM105
• Common Device Name: JAUNDICE METER/BILIRUBINOMETER
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS INC; 6 tech drive; andover MA
• 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: 18777815
• Report Number: 2510954-2024-00004
• Device Sequence Number: 18185138
• Product Code: MQM
• UDI-Device Identifier: 04049098000246
• UDI-Public: (01)04049098000246(11)230913(93)MU20105-25
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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: 01/11/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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 Age: 4 DA
• Patient Sex: Unknown
• Patient Race: White