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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : device evaluated by manufacturer, investigation ongoing.
Event or Problem Description
The customer reported that a jaundice meter had multiple low readings when compared to the tsb.Additional information regarding the low readings, patient age and conditions was requested.No patient injury or death was reported.
Additional Manufacturer Narrative
A complaint was received regarding a draeger jm105 jaundice meter where the customer states the tcb values were out of tolerance when compared to tsb values.No adverse patient impact was reported.The customer provided a data sheet and the answers to the clinical questions however, despite several requests for the additional information needed on their data sheet in order to obtain a complete analysis (the hours of life of the patients and skin type) this information was not made available.The device was sent to telford for analysis and according to the engineer's 19apr24 email his pre calibration assessment found that the meter passed the pre-inspection test, and the values given were within tolerance.He recalibrated the device for customer satisfaction and according to service note report (b)(4) the new average of values provided a new tolerance range.The engineer then created the new door label for the customer's charging base reflecting the after-calibration tolerance range and the device was shipped back to the customer.According to the 22may24 email correspondence from the director of quality, the customer stated that they compared some values of the returned jm105 with their older philips meter prior to conducting clinical labs and were reporting that the jm105 values were still outside of the 1.5 standard deviation as defined by drager in the instructions for use (ifu).The director of quality requested the jm105 be returned for further analysis and after discussion with sales and service sent the customer a brand-new unit.The jm105 underwent another pre-inspection using the test software and it was found that the device was still within tolerance, and according to the engineer's 31jul24 email, the short and long waves during the light checker test were also within range.Another recalibration was performed on the meter with the values again being within range and similar to the pre calibration values.Because no malfunction was found with the device and the inability to obtain a complete analysis of the customer's original data, an exact root cause of the inconsistent readings cannot be determined.The product risk management report (prmr) was reviewed, and no new risks were identified.Product quality was notified of this issue and determined no further action was required as the field failure rate is acceptable.
Event or Problem Description
The customer reported that a jaundice meter had multiple low readings when compared to the tsb.Additional information regarding the low readings, patient age and conditions was requested.No patient injury or 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: 19203890
• Report Number: 2510954-2024-00007
• Device Sequence Number: 18130660
• Product Code: MQM
• UDI-Device Identifier: 04049098000246
• UDI-Public: (01)04049098000246(11)230505(93)MU20105-24
• 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): 08/23/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown