Nova biomedical (nova) was made aware of a potential issue regarding analysis of glucose results during the treatment of a patient while using an unidentified nova statstrip glucose meter.The user indicated the meter was asking for a sample to be applied to the disposable test strip of lot 0319098249, but it did not recognize when the sample was applied.The meter recognized the strips when inserted but did not analyze the sample when applied.This was repeated with another test strip of the same lot which resulted in the same error.Because of this, results could not be obtained and no patient harm or adverse treatment due to the lack of results was reported.
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Udi: (b)(4).No product was returned to nova biomedical for investigation.No manufacturer retains of the test strip lot 0319098249 were available for testing due to the age of the consumable which was already expired at the time nova biomedical was made aware of the alleged malfunction.The similar lot 0320153249 was tested in place of the reported lot as this was one of the oldest lots still viable for use.The alternate test strips were tested using five retained meters during analysis of multiple samples.During this usage, the reported error was not seen with the retained strips and could not be reproduced as all used test strips and meters were able to produce accurate results after applying the sample.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 retains of similar aged 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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