MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CARE, INC. ACCU-CHEK INFORM II; GLUCOSE DEHYDROGENASE, GLUCOSE

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 10/10/2016

Event Type  malfunction  

Event Description

Accu-chek is frozen; it says it's docked and it's not.

• Brand Name: ACCU-CHEK INFORM II
• Type of Device: GLUCOSE DEHYDROGENASE, GLUCOSE
• Manufacturer (Section D): ROCHE DIAGNOSTICS CARE, INC.; mike leslie; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 6098920
• MDR Text Key: 59745694
• Report Number: 6098920
• Device Sequence Number: 1
• Product Code: LFR
• 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: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1