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 started.A follow up report will be submitted upon completion.
Event or Problem Description
The customer reported the readings of the jaundice meter reads outside specification, standard acceptable level of error for the drager is +/- 1.5 points 66% of the time when compared to serum bilirubin.In the lower direction may not be obvious to the user and may not prompt a blood test for verification which could lead to a delay in required treatment.There was no report of adverse patient impact.
Additional Manufacturer Narrative
Service records show that this jm105, serial number: (b)(6) was delivered to the customer on (b)(6) 2024 with dates of their data readings beginning on (b)(6) 2024 as one of their data sheets shows.Several attempts were made to determine when exactly the customer noticed readings outside the standard deviation and if this was a sudden change with the meter values, if the customer was performing the light checker test and the values they were receiving, as well as the additional required data such as skin type and hours of life of the patients on the data sheet that was provided however, the customer did not respond with this information.Without further information or the meter, itself for analysis, which was also requested, an exact root cause cannot be determined at this time.The instructions for use (ifu) informs the user that the jm105 is not intended as a standalone screening device for diagnosis of hyperbilirubinemia.It should be used as a screening device with other clinical signs and laboratory measurements including tsb blood readings before determining a patient's condition or clinical treatment.
Event or Problem Description
The customer reported the readings of the jaundice meter reads outside specification, standard acceptable level of error for the drager is +/- 1.5 points 66% of the time when compared to serum bilirubin.In the lower direction may not be obvious to the user and may not prompt a blood test for verification which could lead to a delay in required treatment.There was no report of adverse patient impact.

• 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 ; 9784097390
• MDR Report Key: 21437351
• Report Number: 1220063-2025-00014
• Device Sequence Number: 4606290
• Product Code: MQM
• UDI-Device Identifier: 04049098000246
• UDI-Public: (01)04049098000246(11)240612(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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2024
• 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