MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH ONETOUCH VERIO BLOOD GLUCOSE METER TEST STRIPS; GLUCOSE DEHYDROGENASE, GLUCOSE

Lot Number 4607334

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2020

Event Type  malfunction  

Event Description

This complaint pertains to the onetouch verio test strip manufactured by lifescan.I check my blood glucose level three times per day as instructed by my physician.I purchase the above noted test strips in packages of 100 test strips directly from my pharmacy by prescription.Here is my complaint: in one box of 100 test strips, it is not unusual to have approximately 20 tests strips that are defective.To give you an example, i would clean and use a lancet on my finger and fill the test strip, and my meter will read, "fill problem" (when the strip is properly filled with blood).This has gone on for years, with varying numbers of unusable test strips, but with this particular package of strips it presents a problem for me because i have had to discard so many unusable strips and now the pharmacy will not refill my prescription because they say it is too early and insurance will not cover more strips until august.I have brought this problem to the attention of both my physician and pharmacy.

• Brand Name: ONETOUCH VERIO BLOOD GLUCOSE METER TEST STRIPS
• Type of Device: GLUCOSE DEHYDROGENASE, GLUCOSE
• Manufacturer (Section D): LIFESCAN EUROPE GMBH
• MDR Report Key: 10295162
• MDR Text Key: 199732485
• Report Number: MW5095590
• Device Sequence Number: 1
• Product Code: LFR
• 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: 03/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2021
• Device Lot Number: 4607334
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 91