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

Catalog Number 06453970170

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2018

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 customer received the following results on the aviva system within 10 minutes: 19.1 mmol/l and 4.6 mmol/l.No adverse event reported.Return of the suspect device was requested for evaluation.

• 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
• Manufacturer (Section G): ROCHE DIABETES CARE, INC.; 9115 hague road; na; indianapolis IN 46250 1025
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 7646426
• MDR Text Key: 112718941
• Report Number: 3011393376-2018-02723
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 06453970170
• Device Lot Number: 497455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 08/29/2018
• Supplement Dates FDA Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2018
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR