On january 20, 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 on january 20, 2023.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 inspection.The retain test strips passed visual inspection 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 january 25, 2023, investigation was completed.The complaint was confirmed.Investigation has not identified any evidence that there is a systemic issue within the subject lot relating to miscut strips and concluded that 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.
|