MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT VERIO TEST STRIPS; GLUCOSE MONITORING SYS/KIT

Lot Number 4469129

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

See incident description for device evaluation.

Event Description

The lay user/patient's test strips have been returned and evaluated by lifescan product analysis with the following findings: the test strips failed testing; the reported issue was confirmed.The test strips were found to have been sticking together.This could be due to static or small amounts of adhesive.During visual inspection of the returned test strips, the strips come apart easily when handled.Complaints relating to the reported product were evaluated.It was concluded that the number of complaints for the product did not breach thresholds indicative of a systemic issue.On (b)(6) 2019, the lay user/patient contacted lifescan (b)(4), alleging that their ot verio test strips were sticking together.This complaint was initially ruled out because during customer services troubleshooting, there was no indication to reasonably suggest that the product malfunctioned and there was also no allegation of an adverse event as a result of the reported issue.

• Brand Name: OT VERIO TEST STRIPS
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: oyinkan donaldson ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8648713
• MDR Text Key: 146349338
• Report Number: 3008382007-2019-01784
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/09/2019

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 Lot Number: 4469129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/09/2019
• Initial Date Manufacturer Received: 05/09/2019
• Initial Date FDA Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1