Roche received complaints alleging invalid and/or false positive results with the cobas® sars-cov-2 & influenza a/b test for use on the cobas® liat® system for one or more targets (sars-cov-2, influenza a, influenza b).When reviewing the customer-provided data associated with the reported invalid and false positive results, abnormal pcr curves were observed.Per the on-going investigation, several potential causes for the abnormal pcr growth curves leading to invalids and false positives have been identified.These include tube leaks, abnormal pcr steps, and loose thermal sensor wiring.Overall across the installed base, these issues from product use may occur sporadically.For invalid or false positive influenza results, adverse health consequences are not likely.For invalid sars-cov-2, adverse health consequences are not likely since detectability is high and testing can be performed on alternative platforms.For erroneous positive sars-cov-2 results, there is the possibility of adverse health consequences in high risk individuals.As stated in the instructions for use, clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.A cobas liat software update to better identify the thermal sensor errors and a new cobas® sars-cov-2 & influenza a/b script to better detect abnormal pcr curves have been launched.The implementation of both the software and the updated script have shown a reduction in the calculated false positive rate.Consignees have been notified.(b)(4).
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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.The customer alleged discrepant results generated for the cobas® sars-cov-2 & influenza a/b (scfa) assay.A customer from the united states alleged that they received potential false positive results for patients¿ samples.During review of customer-provided data three runs tested with kit lot #10907u expiration date 08/31/2022 were identified to have generated potential false positive results for patients¿ samples tested with the cobas® sars-cov-2 & influenza a/b (scfa) assay.Runs # (b)(6) both generated sars-cov-2 positive, influenza b positive results for 2 patient¿s samples tested and analyzed on the cobas® liat® system ((b)(4)).On (b)(6) 2021 run (b)(6) generated an influenza b positive result for a 3rd patient¿s sample tested and analyzed on the cobas® liat® system ((b)(4)).The patient¿s same sample was repeat tested and analyzed on a different cobas® liat® system (s/n not provided) that generated an influenza b negative result that was reported out to the patient and/or personnel treating the patient.No patient details were made available for patients¿ 1 & 2, nor was information regarding repeat testing for those 2 patients provided.No harm or injury was indicated.No information on sample collection or handling was provided.Three (3) mdrs will be filed one for each sample as per fda guidance.
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