MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. DRAGER JAUNDICE METER, MODEL JM-103; BILIRUBIN METER

Model Number MU20606

Device Problem Programming Issue (3014)

Patient Problem No Information (3190)

Event Date 05/22/2018

Event Type  malfunction  

Event Description

The meter (jm-103) has a value of 1- that indicates one more flash needs to be completed before the numbers can be averaged and the result is calculated.The problem is that this number has the mg/dl under it which makes it really seem like a result.Extremely easy to misread and i'm surprised this doesn't happen more often.Granted, the second screen does have 2 dashes before the value and isn't in a decimal format, but still potential for error (obviously).

• Brand Name: DRAGER JAUNDICE METER, MODEL JM-103
• Type of Device: BILIRUBIN METER
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA 18969
• MDR Report Key: 7573133
• MDR Text Key: 110231628
• Report Number: 7573133
• Device Sequence Number: 1
• Product Code: MQM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2018

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: Nurse
• Device Model Number: MU20606
• Device Catalogue Number: JM-103
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1