Section a.Patient information: no further patient information was provided by the customer.The complaint investigation for falsely elevated lactate dehydrogenase (ldh) results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not completed as returns were not available.A review of tickets determined that there is normal complaint activity for ldh reagent lot 42231un20.Trending review did not identify any trends for falsely elevated results for the product.Quality control has been in range and the proficiency testing has been acceptable.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the lactate dehydrogenase (ldh) reagent, lot number 42231un20 was identified.
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