Udi: (b)(4).No product was returned to nova biomedical for investigation.The manufacturer retains of the test strip lot: 0321069249 were tested using five retained meters.The test strips were used during analysis of multiple samples.During this usage, the reported error was not seen with the retained strips and the reported problem could not be reproduced.Device history record (dhr) reviews were performed for the test strips being used at the time of the event by a quality control investigator.The reviews included an assessment of the production, testing, and release of the meter and test strips.No abnormalities or concerns were noted, and the dhr indicated the released product met all specifications.The conclusion of the investigation is the reported customer complaint could not be reproduced after testing the retained test strips.A conclusive root cause was unable to be identified, and nova will continue to monitor for recurrence of similar events.
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