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

Catalog Number 06453988016

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2021

Event Type  malfunction  

Manufacturer Narrative

The event occurred outside of the united states.While this product is not sold in the united states, it is like or similar to a product marketed in the united states.

Event Description

It was reported the patient received the following results within 15 minutes: 13.0 mmol/l, 21.0 mmol/l, 6.0 mmol/l and 10.0 mmol/l.

Manufacturer Narrative

D4 and h4 updated.

• Brand Name: ACCU-CHEK AVIVA TEST STRIPS
• Type of Device: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11414165
• MDR Text Key: 234726560
• Report Number: 3011393376-2021-00574
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 06453988016
• Device Lot Number: 498829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Date Manufacturer Received: 05/18/2021
• Patient Sequence Number: 1