MAUDE Adverse Event Report: ROCHE DIAGNOSTIC OPERATIONS INC. ACCU-CHEK AVIVA PLUS GLUCOSE TEST STRIPS

Catalog Number 06908268001

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

Patient Problem Hypoglycemia (1912)

Event Date 05/15/2018

Event Type  Injury  

Event Description

I recently received a notice from (b)(6) pharmacy regarding lots of roche accu-chek aviva plus glucose test strips indicating that certain lots were being recalled because strips were being recalled because strips were not being recognized in the roche aviva glucometer or were giving incorrect results.Although i did not have any of the lot numbers listed in the notice.I have acquired a lot number (497326, exp date 05/31/2019) from a different source ((b)(6) pharmacy) that was one digit off from the one of the lots listed in the cvs recall notice (497325, exp 05/31/2019).The listed lot (497325) was for a package of 50 test strips, while my lot number was for a package of 100 test strips.I had the exact same problem listed in the recall notice, that is, i had multiple strips (5 so far) that were not recognized by the meter over the past month, and i may have had at least one incorrect reading that was a basis for an insulin dose that caused me to develop a hypoglycemic episode around (b)(6) 2018 (glucose dropped to 45 within 30 after injection).I have been using this same brand of test strips for several years and have never had a strip that was not recognized by the glucometer, which was i found this lot unusual.I suspect that i may have had inaccurate readings in the past, and may have undergone hypoglycemic episodes as a result of those, but i accepted that as the relative inaccuracy of measuring blood glucose in such a manner.This if the first time i received a recall notice with a lot number so close to mine with the identical problems described in the recall notice, especially the nonrecognition of the test strips, which had never happened before.I contacted roche to report the problem with my lot number (497326) and to ask them if they had received similar concerns from other users.My concern is that i get a limited number of strips under medicare for daily testing, and i don't have many extras (10 for a 90 day supply) to use if strips that don't work or to retest my blood glucose several times if i think the reading is incorrect.I need to have add'l strips in case i need to test my blood sugar if a hypoglycemic episode occurs (can use 5 or more strips in one episode while monitoring my recovery from hypoglycemia - a potentially lethal event).I have not received a response from roche.I still have approx 35 strips left from the original 100 and hope that i don't have any add'l strips that are not recognized or give incorrect readings before i get my next refill.Time is of the essence since other users may be in the same predicament as myself with this lot number, and a potentially lethal event may occur if an incorrect reading from a strip in this lot leads to a hypoglycemic episode or not having working strips when one needs them for monitoring blood glucose levels.

• Brand Name: ACCU-CHEK AVIVA PLUS GLUCOSE TEST STRIPS
• Type of Device: ACCU-CHEK AVIVA PLUS GLUCOSE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTIC OPERATIONS INC.
• MDR Report Key: 7560628
• MDR Text Key: 110037528
• Report Number: MW5077586
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 06908268001
• Device Lot Number: 497326
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 109