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

Lot Number 4812083

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

On (b)(6) 2022, the reporter contacted lifescan alleging bent test strip.There was no indication that the product caused or contributed to an adverse event.Similar complaints for this issue were trended for the test strip lot.It was concluded that the number of complaints for the lot did not breach thresholds indicative of a systemic issue.The complaint was further investigated based on photographic evidence received on (b)(6) 2022.A device history record review was performed on the subject test strip lot.The review did not identify anything that could adversely impact product performance or function.In addition, the retain test strips were subjected to visual testing.The retain test strips passed visual testing with no defects identified.Lifescan also conducted a strip lot evaluation and concluded that the complaints associated to this lot do not require escalation and no systemic issue was observed.The lay user/patient¿s strips have been returned and evaluated by lifescan product analysis with the following findings: the test strips passed functional testing with no faults found.On (b)(6) 2022, investigation was completed.The reported issue was confirmed.The test strips were found to have been mis-cut during slitting and vialing.This investigation has not identified any evidence that there is a systemic issue within lot 4812083 relating to miscut strips.No further escalation is required.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

Manufacturer Narrative

The lay user/patient¿s test strips have been further evaluated by lifescan product analysis with the following findings: the strip response from additional performance testing on the customer returned strips included error 4 and inaccurate control low which are both attributable to the primary diagnostic defect of the test strip being mis cut.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

• Brand Name: OT VERIO TEST STRIP
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; UK IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness IV2 3-ED ; UK IV2 3ED ; 1463383679
• MDR Report Key: 14540001
• MDR Text Key: 293359028
• Report Number: 3008382007-2022-04311
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• PMA/PMN Number: K093745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

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: 4812083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/30/2022
• Supplement Dates Manufacturer Received: 06/27/2022
• Supplement Dates FDA Received: 06/28/2022
• 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