SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM SARS-COV-2 TOTAL (COV2T); SARS-COV-2 IMMUNOASSAY,
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Model Number N/A |
Device Problem
False Positive Result (1227)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Mdr 1219913-2020-00675 was filed on december 28, 2020.Correction - january 5 2021: it was identified that samples (b)(6) were tested on december 4 2020 not december 3 2020 as originally stated.Additional information -january 5 2021: siemens healthcare diagnostics has concluded its investigation of atellica im and advia centaur sars-cov-2 total (cov2t) non-reproducible false reactive results with kit lots ending in 004, 005, 035 and 006.Siemens investigation determined that although non-reproducible false reactive results were observed with multiple kit lots, results indicate the negative percent agreement confidence interval of the kit lots evaluated overlap the confidence interval in the ifu; therefore they are performing within claims and a change in performance has not been confirmed.The ifu states in the limitations section: "this assay should not be used to diagnose or exclude acute infection.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 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." 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.The atellica im sars-cov-2 total (cov2t) lot 005 is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.
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Manufacturer Narrative
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Siemens is investigating.The limitations section of the instructions for use states: "this assay should not be used to diagnose or exclude acute infection.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 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." 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).
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Event Description
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The customer observed initially reactive (positive) atellica im sars-cov-2 total (cov2t) results that were nonreactive (negative) upon repeat testing on the advia centaur xp.The reactive results were reported to the physician(s) who questioned the results.There are no reports of patient intervention or adverse health consequences due to the discordant cov2t results.
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