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	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported low reading tcb approx 80umol/l against sbr:tcb 173 vs sbr 250 umol/l, tcb 292 vs sbr 378 umol/l.No date or event or other information was provided.No adverse patient impact or death reported.
Event or Problem Description
The customer reported low reading tcb approx 80umol/l against sbr:tcb 173 vs sbr 250 umol/l, tcb 292 vs sbr 378 umol/l.No date or event or other information was provided.No adverse patient impact or death reported.
Additional Manufacturer Narrative
It was reported to draeger that the jm105 had lower readings than the total serum bilirubin (tsb).No adverse patient impact was reported.The customer responded by answering some of the clinical questions however, the customer supplied only 2 jm105 values.Despite many attempts asking for the customer to provide a data sheet, which includes crucial information to determining clinical use and values being received, this information was not made available.One of the tsb readings provided (21.9) is beyond the scope of the jm105.According to the instructions for use (ifu) the measurement range for the jm105 is 0.0 mg/dl to 20.0 mg/dl.The customer provided the tcb reading in this case to be 16.9 which would likely prompt clinicians to provide further care however, without the additional clinical data (hours life of the patient, skin type, blood processing time) a definitive determination cannot be made.In addition, the ifu states that the jm105, "is not intended as a stand-alone screening device for diagnosis of hyperbilirubinemia.It is used as a screening device with other clinical signs and laboratory measurements." the meter was returned to drager for analysis and the draeger field service engineer (fse) found the pre-calibration values of the meter to be within range of the tolerances given on the base.The draeger fse recalibrated the device under warranty for customer satisfaction, produced a calibration certificate certifying the device was within the target range and ready for clinical use.Due to the lack of tcb and tsb data and other information indicating how the user was taking readings, the skin type and hours of life of the patients that can affect values, or the nomogram used by the customer to prompt further care, a root cause cannot be determined.The device was returned to the customer and the customer was retrained on how to use the device.No further issues have been 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: 19855786
• Report Number: 2510954-2024-00034
• Device Sequence Number: 15073614
• Product Code: MQM
• UDI-Device Identifier: 04049098000246
• UDI-Public: (01)04049098000246(11)230327(93)MU20105-24
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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: 07/01/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2023
• 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 Sex: Unknown