MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC JM-105 JAUNDICE METER; JAUNDICE METER/BILIRUBINOMETER

Model Number MU20105

Device Problem Low Readings (2460)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2023

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of this investigation.

Event Description

It was reported that the jm105 jaundice meter was measuring incorrectly, the reading were lower than expected.No adverse patient impact was reported.

Manufacturer Narrative

Interviews with the customer revealed that the expressed concern was related to the aspect that the readings of the jm-105 transcutaneous bilirubin (tcb) were almost 3 points lower than the total serum bilirubin (tsb) blood test results.The involved dräger device was subject to an in-depth evaluation whereby no deviations from specification could be found.Before the device was returned to the customer, a preventive maintenance was performed.In particular, the battery was replaced, an upgrade to the firmware was made and a recalibration was performed.Dräger came to the conclusion that the reported issue must be attributed to application aspects.Dräger recommends that - if the measurement with the jm-105 indicate the necessity of a blood gas analysis, the latter shall be performed within 60 minutes of time.It could be revealed that the lab testing at the user facility takes at an average 2 to 4 hours until results are available.It was concluded that this delay was the major factor for the divergence between the values of both measurement methods.Additionally, it could be revealed that even the jm-105 readings with the biggest divergence to the tsb results are still in the range to trigger the adequate clinical decision.

Event Description

It was reported that the jm105 jaundice meter was measuring incorrectly, the reading were lower than expected.No adverse patient impact was reported.

• Brand Name: JM-105 JAUNDICE METER
• Type of Device: 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
• Manufacturer Contact: 3135 quarry road; telford, PA ; 9783798000
• MDR Report Key: 17332528
• MDR Text Key: 319127634
• Report Number: 2510954-2023-00011
• Device Sequence Number: 1
• Product Code: MQM
• UDI-Device Identifier: 04049098000246
• UDI-Public: (01)04049098000246(11)190621(93)MU20105-18
• Combination Product (y/n): N
• PMA/PMN Number: K133175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

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
• Device Operator: Health Professional
• Device Model Number: MU20105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/17/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1