MAUDE Adverse Event Report: DRAEGER MEDICAL INC.; BILIRUBIN METER

Model Number JM-103

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/07/2015

Event Type  malfunction  

Event Description

Bilirubin meter gave incorrect readings for patient.If the test button is held for fifteen seconds or more, the output changes from mg/liter to micromoles/decaliter.

• Type of Device: BILIRUBIN METER
• Manufacturer (Section D): DRAEGER MEDICAL INC.; 3135 quarry road; telford PA 18969
• MDR Report Key: 5221736
• MDR Text Key: 31106559
• Report Number: 5221736
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/22/2015,11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: JM-103
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2015
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO