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

Lot Number 5707819

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Event Description

On december 11, 2023, the reporter contacted lifescan alleging a strip cut issue.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.A batch record review was completed for 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.On december 13, 2023, investigation was completed.The reported issue was confirmed.The test strips were found to have been miscut during slitting and vialing.This investigation has not identified any evidence that there is a systemic issue within the subject test strip lot relating to miscut strips.No further escalation is required at this time.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

See incident description (b5) for device evaluation.

• Brand Name: OT VERIO TEST STRIP
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; dammstrasse 19; 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: 18324351
• MDR Text Key: 330480893
• Report Number: 3008382007-2023-00072
• 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: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 5707819
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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