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 (b)(6) alleged discrepant results for sars-cov-2 on the cobas liat system.(b)(6).The cobas sars-cov-2 & influenza a/b for use on the cobas liat system package insert indicates that the cobas® liat® system has an lod of 0.012 tcid50/ml for sars-cov-2, which converts in pfu/ml to being over twice as sensitive as the genexpert.Therefore, it is conceivable that the cobas® liat® system will detect sarscov2 when the viral load is low, while the genexpert requires a higher viral load in the sample for detection.The results were reported out to the respective patients.It was noted that for patient 1, there was concern of the patient being exposed to infection as a consequence of incorrect results from cobas liat.No further information has been provided whether any medical treatment was given to the patient based on the discrepant results.No harm or injury was reported for patient 2.No issues were identified with the kit during the investigation.2 mdr's will be filed, one for each of the 2 patients.
|