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.
Event or Problem Description
The customer reported that the jm 105 had low readings when compared to tsb readings throughout the month of march.No patient injury or death was reported.
Additional Manufacturer Narrative
It was reported to draeger that the drager jm105 jaundice meter was providing inconsistent/low readings when compared to tsb values.No adverse patient impact was reported.The data that was provided was incomplete and a request was made to obtain the missing information, such as hours of patient life and skin type, to perform a complete analysis.The customer stated that no further data was available.A clinical application specialist reported that she visited the facility to observe the customer using the device.The clinical application specialist stated that it appeared that the users were performing every step of the process correctly and the meter was also set up accordingly.The device was returned to drager for further evaluation and the value ranges are within tolerance level of the acceptable range of (-2.3 to -0.3).As a precaution the customer was provided with a warranty replacement device.The instructions for use (ifu) provide the guidance that 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.
Event or Problem Description
The customer reported that the jm 105 had low readings when compared to tsb readings throughout the month of march.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 ; 2156602400
• MDR Report Key: 19203808
• Report Number: 2510954-2024-00008
• Device Sequence Number: 20838409
• Product Code: MQM
• UDI-Device Identifier: 04049098000246
• UDI-Public: (01)04049098000246(11)231212(93)MU20105-25
• Combination Product (Y/N): N
• PMA/510(K) Number: K133175
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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