An outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report an atellica im sars-cov-2 total (cov2t) reactive (positive) result was obtained from one sample and the result was considered discordant compared to testing with an alternate method.The sample was also reactive with a different lot of atellica im sars-cov-2 total.Qc was in range at the time of testing.The interpretation of results section of the instructions for use (ifu) states: "the system reports advia centaur cov2t assay results in index values or u/ml and as non-reactive or reactive: non-reactive: < 1.00 index (u/ml).These samples are considered negative for sars-cov-2 antibodies.Reactive: =1.00 index (u/ml).These samples are considered positive for sars-cov-2 antibodies." the calculation of results section of the ifu states: "conversion formula: 1.00 index value = 1.00 u/ml" the instructions for use states in the limitations section: "results are not intended to be used as the sole basis for patient management decisions.Test results should be interpreted in with clinical observations, patient history, epidemiological information, and other laboratory findings." "a reactive test result does not exclude past or present infection by other coronaviruses, such as sars-cov-1, mers-cov, hku1, 229e, nl63, or oc43, or due to cross-reactivity from pre-existing antibodies or other possible causes." a false positive/reactive result would not be used in isolation and would be correlated with clinical history.Additional laboratory testing would be used to determine specific antibody presence.Although there is no potential for serious injury in this case, an mdr will be reported to the fda as a requirement of the emergency use authorization (eua).Siemens healthcare diagnostics is investigating.Mdr 1219913-2022-00088 and mdr 1219913-2022-00089 were filed for the same event.
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Siemens filed the initial mdr 1219913-2022-00089 on march 18, 2022.March 24, 2022, additional information: an outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report an atellica im sars-cov-2 total (cov2t) reactive (positive) result was obtained from one sample and the result was considered discordant compared to testing with an alternate method.The sample was also reactive with a different lot of atellica im sars-cov-2 total.Siemens healthcare diagnostics has completed the investigation into alleged difference in the cov2t result between atellica im sars-cov-2 total (cov2t) and an alternative method.Quality control and calibrations were appropriate at the time of testing.No patient history was available.This appears to be a sample-specific issue however without further medical history siemens healthcare is unable to determine root cause.No product nonconformance was identified.In section h6, the investigation finding, and investigation conclusion codes were updated.Mdr 1219913-2022-00088 supplemental 1 and mdr 1219913-2022-00089 supplemental 1 were filed for the same event.
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