MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GMBH COBAS BLOOD GLUCOSE METER; BLOOD GLUCOSE MONITOR

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

Patient Problem No Information (3190)

Event Date 02/26/2016

Event Type  Injury  

Event Description

Blood sugar in glucose point of care lab at 6 am showed 471.Night nurse gave report to day nurse and stated that patient blood sugar at 6 am was 135 and patient was covered with 2 units of regular insulin.Patient blood sugar was rechecked at 0938 and it was 157, using the same machine that showed 471 at 6 am.Different machine was used to recheck patient blood sugar again at 1003 and blood sugar was 103.Patient did not have any breakfast until 1030 am.

• Brand Name: COBAS BLOOD GLUCOSE METER
• Type of Device: BLOOD GLUCOSE MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 5473266
• MDR Text Key: 39445364
• Report Number: 5473266
• Device Sequence Number: 1
• Product Code: CFR
• 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: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/29/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/29/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29 YR