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 a jaundice meter 105 that had both low and high readings.The meter had been in use a few months.The customer stated that the tcb readings have been lower than the serum results by 3-4 points with a couple results greater than that, and that the staff would have changed treatment if the users had not collected serum.The staff reportedly calibrate the unit before every use.No adverse patient impact or death was reported.
Event or Problem Description
The customer reported a jaundice meter 105 that had both low and high readings.The meter had been in use a few months.The customer stated that the tcb readings have been lower than the serum results by 3-4 points with a couple results greater than that, and that the staff would have changed treatment if the users had not collected serum.The staff reportedly calibrate the unit before every use.No adverse patient impact or death was reported.
Additional Manufacturer Narrative
A complaint was received regarding a draeger jm105 jaundice meter that was providing inconsistent readings when compared to tsb values.No adverse patient impact was reported.The customer provided a data sheet and the answers to the clinical questions and upon review of the limited data they provided, the five eligible readings were low when compared to tsb results.An initial request was made for further data from the customer, but additional readings were not available.In the original email correspondence on (b)(6) 2024 the customer stated that they discovered that the light checker test is not performed before every measurement, but when they did check it, the s value was reading out of range.Several attempts were made to determine how often the user was performing the light checker test, exactly when they realized the s value was out of range and if the user received the "measure reading checker" message when the device was first powered on, but this information was not made available.The device was returned to telford for analysis and according to the engineer's (b)(6) 2024 email, the s value was confirmed to be out of range.A recalibration was recommended and the after-calibration check confirmed that all three values (long, short and delta) were within range on the house checker base.According to the calibration certificate the software test of the device using the calibrated checker sets also shows that the values were within tolerance after the recalibration.The service note confirms that all functions passed, and the device was sent back to the customer.The last calibration of the device was (b)(6) 2023 and the root cause of the meter showing out of range values during the light-checker test and needing recalibration before the 12-month timeframe, is unknown at this time.The ifu explains that the "measure reading checker" will appear each time the device is switched on and cannot be cleared until this light checker test is performed.The ifu further notes, that jm105 values should be periodically compared to serum bilirubin results for quality control purposes and that if values are out of range with the charging base, drager service should be contacted.The jm105 jaundice meter is a screening device to be used with other clinical signs and laboratory measurements before making treatment determinations and is not intended to be used a stand-alone device for diagnosis of hyperbilirubinemia is also stated in several sections of the jm105 instructions for use (ifu).

• 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: 20246069
• Report Number: 2510954-2024-00040
• Device Sequence Number: 15279085
• Product Code: MQM
• UDI-Device Identifier: 04049098000246
• UDI-Public: (01)04049098000246(11)231211(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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: 08/14/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown