In light of the covid-19 pandemic and the subsequent emergency use authorizations (euas) for sars-cov-2 diagnostic tests, the agency has requested heightened reporting beyond the reasonably suggests requirements of 803 to include allegations of false positive or false negative results independent of harm or malfunction or off-label use.Pursuant to the agency¿s instruction, we hereby submit this mdr.A customer alleged a discrepant result for a single patient while using the cobas sars-cov-2 & influenza a/b test on the cobas liat system.The alleged sample initially generated negative results for sars-cov-2, influenza a, and influenza b.The same patient sample was retested on the cobas influenza a/b & rsv assay and generated a positive result for influenza b (negative for influenza a and rsv).The results were released.No harm was alleged.An investigation was conducted to evaluate the customer issue.Per fda¿s eua guidance, 1 mdr will be filed.
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