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 pooling 10 samples with the cobas® sars-cov-2 & influenza a/b nucleic (scfa) acid test, for use on the cobas® liat® system.Note that pooling samples is considered off-label.The customer reported 1 sample generated sars-cov-2 positive, from a pool of 10 samples that were tested with cobas® liat® system serial number ((b)(4)).Each of the 10 individual sample was repeated on a different cobas® liat® system and generated negative results.No additional details on sample id were provided.The individual negative results were reported.The same pool was retested on the same cobas® liat® system used for the original testing of the pool ((b)(4)) and generated a positive result for sars-cov-2.No apparent harm or injury occurred in relation to the event.An investigation was conducted to evaluate the customer¿s allegation.One mdr will be filed for the alleged discrepant results generated for that one pool.
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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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