MAUDE Adverse Event Report: ROCHE DIABETES CARE INC. ACCU-CHEK AVIVA PLUS GLUCOSE TEST STRIPS; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Lot Number 497291

Device Problems False Reading From Device Non-Compliance (1228); Nonstandard Device (1420); Defective Component (2292)

Patient Problem No Information (3190)

Event Date 05/29/2018

Event Type  malfunction  

Event Description

On (b)(6) 2018, i was notified by (b)(6) that the accu-chek aviva glucose strips i have been using were recalled by the manufacturer because of a defect that could result in incorrectly higher or lower blood glucose readings.I followed instructions on the roche website and requested that the defective strips be replaced, but i was advised that i would not receive new strips for 7-10 days.This is very problematic because i cannot safely go that long without testing my blood glucose.I went to (b)(6), where i had obtained the test strips, and i was told that there was nothing that (b)(6) could or would do to help my situation.I would also note that (b)(6) did not notify me of the recall until 3 weeks after the recall was made, so i went all of that time relying on potentially inaccurate blood glucose readings.I believe that both roche and (b)(6) were remiss and did not act in an appropriate manner or in the patient's best interests.

• Brand Name: ACCU-CHEK AVIVA PLUS GLUCOSE TEST STRIPS
• Type of Device: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): ROCHE DIABETES CARE INC.
• MDR Report Key: 7560561
• MDR Text Key: 110029378
• Report Number: MW5077580
• Device Sequence Number: 1
• Product Code: NBW
• 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: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Lot Number: 497291
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 82