Review of the instrument's run data showed the 3 alleged runs made a potential false positive call for all 3 targets due to abnormal pcr growth curves.The device was requested to be picked up for repair.(b)(6).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.Consignees have been notified.The customer issue has been alleged on the cobas liat system, product code: occ, catalog number 07341920190 and udi (b)(4).The test used on the cobas liat system is the cobas sars-cov-2 & influenza a/b test for use on the cobas liat system ((b)(4), product code: qjr).The product catalog number for the test is 09211101190.(b)(4).
|
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 spain alleged discrepant results generated when using a cobas® sars-cov-2 and influenza a/b nucleic acid test for use on the cobas® liat® system.Patient 1 generated sars-cov-2 positive, influenza a positive, influenza b positive.Patients 2 and 3 generated flu a positive results.Repeat testing for patients 1 and 2 was conducted on a different platform and generated negaive results.Repeat testing for patient 3 was conducted on a different cobas® liat® system and generated negative results.The positive results were not release to the patient.No harm is alleged.An investigation was conducted to evaluate the customer¿s issue.Per the fda guidance three (3) mdrs will be filed; one per patient.
|