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

Catalog Number 06453970054

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2018

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.This case, with patient identifier (b)(6), is related to case with patient identifier (b)(6).

Event Description

Customer reportedly received the following results on the aviva system within 10 minutes: 29 mg/dl or 30 mg/dl (strip lot: 496822) and 120 mg/dl (strip lot: asku).Results were obtained using different strip lots.No adverse event reported.Return of the suspect device was requested for evaluation.

Manufacturer Narrative

The suspect device (test strips) that were returned by the customer expired before the investigation could be completed.The manufacturer periodically tests retention stock for all produced lots until each lots expiration date.There were no issues with retention testing for this lot.

• 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: 7646413
• MDR Text Key: 112740103
• Report Number: 3011393376-2018-02721
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/03/2018

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: 08/31/2018
• Device Catalogue Number: 06453970054
• Device Lot Number: 496822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 09/18/2018
• Supplement Dates FDA Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2017
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1