Additional information: b4, g1, g4, g6, h2, h4, h5, h6, h10 corrected information: d2 udi:(b)(4) the user reported an incident with discpreant patient results when compared to a reference analyzer while measuring creatinine with a statprofile prime plus analyzer, serial number (b)(6).This occurred on (b)(6) 2022.The analyzer did not indicate there was a problem with the sample in anyway before producing the results, and the patient received ct contrast prior to the reference analyzer producing a discrepant result.The analyzer and sensors were not returned to nova biomedical for investigation.The manufacturer retains of the sensor used by the customer were unavailable, but retains of a similar lot which was produced the same day with same materials as the sensor in question were available and tested.The sensor produced acceptable values for quality control tests, and precision tests with whole blood samples were within specification.Device history record (dhr) reviews were performed for the analyzer and the consumables in use at the time of the event by a quality control engineer.The reviews included an assessment of the production, testing, and release of the analyzer and consumables.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 using manufacturer retains of a similar lot of sensor card used by the customer.A root cause was unable to be identified, and nova will continue to monitor for recurrence of similar events.
|