An outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report a discordant, non-reactive atellica im sars-cov-2 total (cov2t) result obtained from a patient that was considered discordant compared to the repeat results.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 nonreactive or reactive: nonreactive: < 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 limitations sections of the ifu state: "results are not intended to be used as the sole basis for patient management decisions.Test results should be interpreted in conjunction with clinical observations, patient history, epidemiological information, and other laboratory findings." "a non-reactive test result does not exclude the possibility of exposure to or infection with sars-cov-2.Patient specimens may be nonreactive if collected during the early (preseroconversion) phase of illness or due to a decline in titer over time.In addition, the immune response may be depressed in elderly, immunocompromised, or immunosuppressed patients." be nonreactive if collected during the early (preseroconversion) phase of illness or due to a decline in titer over time.In addition, the immune response may be depressed in elderly, immunocompromised, or immunosuppressed patients." a false negative/non-reactive result would be correlated with clinical history and presentation and may lead to additional testing and/or continued precautions to avoid infection with negligible clinical impact.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.
|
Siemens filed the initial mdr 1219913-2022-00086 on march 18, 2022.An outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report a discordant, non-reactive atellica im sars-cov-2 total (cov2t) result obtained from a patient that was considered discordant compared to the repeat results.Siemens healthcare diagnostics has completed the investigation into alleged difference in cov2t results between replicates on lot 012.Siemens healthcare is unable to rule out preanalytical variables that may have contributed to the imprecision seen in this one sample.Lot 012 has expired so no further testing can be done with this one sample on lot 012.A precision study was run with this patient.10 replicates of the sample were run with lot 013 and all 10 replicate results were non-reactive.Quality control and calibrations were appropriate for both kit lots at the time of testing.No patient history was available, and no further testing could be conducted as the kit lot 012 had expired.This appears to be a sample-specific issue however without further medical history siemens healthcare is unable to determine root cause.The root cause could not be determined.No product nonconformance was identified.
|