MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK AVIVA PLUS TEST STRIPS; GLUCOSE DEHYDROGENASE

Lot Number 497023

Device Problems Incorrect Or Inadequate Test Results (2456); Device Displays Incorrect Message (2591)

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

Event Date 07/31/2017

Event Type  malfunction  

Event Description

Could not get an accurate reading with the accu-check aviva plus test strips.The reading was so much higher than the reading of other strips used before.Errors was displayed on the screen.I used so many trying to get to the problem of what was causing the errors.I stored them in different locations.Finally i gave up trying to use the strips.

• Brand Name: ACCU-CHEK AVIVA PLUS TEST STRIPS
• Type of Device: GLUCOSE DEHYDROGENASE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.
• MDR Report Key: 7591266
• MDR Text Key: 110882092
• Report Number: MW5077790
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2018
• Device Lot Number: 497023
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 73