SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT SARS-COV-2 IGG (SCOVG); 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 10/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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An outside of the united states (ous) customer contacted the siemens customer care center to report an observation of a positive (reactive) advia centaur xpt sars-cov-2 igg (scovg) result that was discordant to alternate test methods.The limitations section of the instructions for use 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." "it is currently unknown how long sars-cov-2 antibodies persist following infection and if the presence of antibodies confers protective immunity." a false positive/reactive result would not be used in isolation and would be correlated with clinical history.At this time, the presence of an immune response cannot be interpreted as confirmation of immunity.Thus, continued precautions to avoid infection will occur 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 is investigating.
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Event Description
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A customer reported a positive (reactive) advia centaur xpt sars-cov-2 igg (scovg) result that was discordant to alternate methods.The customer indicated that the initial result was provided to the physician and were questioned and that a corrected report was issued.There are no reports of patient intervention or adverse health consequences due to the positive (reactive) scovg result.
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Manufacturer Narrative
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Siemens healthcare diagnostics filed mdr 1219913-2021-000524 initial report on 2021-12-30.Additional information - 2022-04-18.Siemens has concluded investigation for a customer observation of a positive (reactive) advia centaur xpt sars-cov-2 igg (scovg) result with lot 012 that was discordant to alternate methods.Complaint lot 012 has since expired, therefore further testing cannot be performed.For the alleged false positive advia centaur xpt scovg sample result, data provided was inconclusive to whether the sample was reactive on scovg as the numeric result indicated a reactive result, but the interpretation provided by the customer was negative.The sample was not repeated on the scovg assay.As per the advia centaur xpt scovg ifu limitations section, "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." siemens's internal data was reviewed for scovg lot 012 and all specifications were being met.No product non conformance has been identified.In section h6, investigation finding and investigation conclusion codes were updated based on the investigation results.
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