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

Lot Number 4764375

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Event Description

On may 17, 2022, the reporter contacted lifescan (lfs) japan, alleging a strip cut issue; the test strips were allegedly deformed.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 may 17, 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 retained test strips of lot# 4764375 were subjected to visual testing.The retain test strips passed visual testing with no defects identified.Lfs 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.On (b)(6) 2022, the lay user/patient¿s test strips were received and subsequently evaluated by lfs product analysis.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.It has been confirmed that the complaints for this hazardous situation are contained within the overall residual risk threshold that is used to monitor safety of the device in the field.Lifescan continues to monitor the complaint rate against risk thresholds and targets set for the device.Currently there is no indication that this issue requires further investigation.Should this change, lifescan will escalate the issue per internal procedures.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: 14915611
• MDR Text Key: 301202783
• Report Number: 3008382007-2022-04321
• 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
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 4764375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2022
• Date Manufacturer Received: 06/07/2022
• 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