MAUDE Adverse Event Report: LIFESCAN EUROPE, GMBH ONE TOUCH VERIO TEST STRIPS; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Device Problem Defective Device (2588)

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

Event Date 01/01/2015

Event Type  malfunction  

Event Description

The test strips for the one touch verio glucose meter have a very high failure rate.I have been sent more by the one touch company a couple times; same result.I have also reported this problem to (b)(6) a couple different ways.I threw out all the containers that had this data; one touch has my reports on this.Fda safety report id# (b)(4).

• Brand Name: ONE TOUCH VERIO TEST STRIPS
• Type of Device: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): LIFESCAN EUROPE, GMBH
• MDR Report Key: 8577756
• MDR Text Key: 144116776
• Report Number: MW5086353
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• 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: 04/30/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 91