Analyzer was returned and inspected.The inspection revealed a hardware defect the analyzer will be sent to the repair depot for service.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.A customer from the us filed a complaint when using the cobas® sars-cov-2 & influenza a/b test assay for use on the cobas® liat® system.System.Review of the system data, identified: 2 potentially discrepant results : run #2187 was identified to have made potential false-positive calls for the influenza a and influenza b targets of the scfa 1.0.2 assay and run #2476 was identified to have made potential false-positive calls for the influenza a target of the scfa 1.1.0 assay.No apparent harm or injury occurred in relation to the event.An investigation was conducted to evaluate the customer¿s allegation.Per the fda guidance two (2) mdrs will be filed one per patient.
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