SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM ANTI-HEPATITIS B CORE TOTAL (HBCT); TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
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Model Number N/A |
Device Problem
False Negative Result (1225)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/02/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A customer from outside the united states reported observation of a nonreactive (negative) anti-hepatitis b core total (hbct) result which was discordant relative to alternate-method testing.Hbct lot information was requested, but not provided.Siemens reviewed the available reagent, instrument, and sample data.Reagent issues and instrument performance problems were ruled out as quality control (qc) results were within acceptable ranges and no issues were reported with other patient samples.The clinical sensitivity section of the atellica im anti-hepatitis b core total (hbct) instructions for use (ifu) indicates that the 95% confidence interval (ci) for resolved sensitivity as 99.09% - 100%, so a certain number of false negative results can be expected for the hbct assay.Based on the available information, the observed discordant result for this one sample is consistent with expected assay performance.Based on the investigation, no product problem was identified.The customer is operational, and no further action is required.
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Event Description
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The customer reports observation of a nonreactive (negative) anti-hepatitis b core total (hbct) result which was discordant relative to alternate-method testing.Hbct lot information was requested, but not provided.In a retrospective comparison of assay results, one patient¿s nonreactive hbct result was identified as discordant, as two alternate-method anti-hbc methods (atellica im hbct2 and another manufacturer's method) produced positive results for the same patient.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.
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