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 generated while using the cobas® sars-cov-2 & influenza a/b nucleic (scfa) acid test for use on the cobas® liat® system.When compared to the results generated with the genexpert cepheid.The customer reported that the initial patient sample was tested with the cobas® liat® system and generated sars-cov2 positive, influenza a positive and influenza b negative.The same sample was retested in the microbiology laboratory with the genexpert cepheid was negative for all 3 targets.The positive results were initially reported and the patient was discharged with a summary stating that they were positive for both sars-cov2 and influenza a.The final report was amended to capture the results of the retest with the genexpert cepheid.No apparent harm or injury occurred in relation to the event.An investigation was conducted to evaluate the customer¿s allegation,.
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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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