SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM ANTI-HEPATITIS B CORE TOTAL (HBCT) ASSAY; 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 10/29/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A united states (us) customer contacted a siemens customer care center (ccc) and reported that discordant, non-reactive anti-hepatitis b core total (hbct) result on a patient sample using lot 190 on an atellica im 1600 analyzer.The non-reactive result was reported to the physician(s), who did not question the result.The initial sample was retested on an alternate instrument, immulite 2000 instrument, the sample produced ¿positive¿ result.The positive result was reported as the correct result to the physician(s).Quality control (qc) was acceptable on the day of the event.Siemens healthcare diagnostics is evaluating the event.
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Event Description
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The customer reports observation of discordant, non-reactive anti-hepatitis b core total (hbct) result on a patient sample using lot 190 on an atellica im 1600 analyzer.The non-reactive result was reported to the physician(s), who did not question the result.The initial sample was retested on an alternate instrument, immulite 2000 instrument, the sample produced a ¿positive¿ result.The positive result was reported as the correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, non-reactive hbct result.
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Manufacturer Narrative
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Siemens filed the initial mdr 1219913-2023-00314 on 08-dec-2023.Additional information ¿ 09-jan-2024: a united states (us) customer reports observation of discordant, non-reactive anti-hepatitis b core total (hbct) result on a patient sample using lot 190 on an atellica im 1600 analyzer.The non-reactive result was reported to the physician(s), who did not question the result.The initial sample was retested on an alternate instrument, immulite 2000 instrument, the sample produced a ¿positive¿ result.The positive result was reported as the correct result to the physician(s).After performing investigation on the affected sample, siemens confirmed that the sample was also hepatitis b surface antigen ii (hbsii) nonreactive, anti-hbs2 (ahbs2) reactive, and hbc igm (ahbcm) nonreactive, which when combined with the hbct reactive result suggest the patient recovered from a previous hepatitis b virus (hbv) infection.Based on siemens review of customer data, atellica im hbct reactive control was recovering on the low side with lot 190 on the day the sample was tested but within 2 standard deviations of historical performance.As this sample was close to the cutoff of 0.50 index the negative result was within the normal variation expected for hbct assay.As stated in the percent agreement section of the atellica im anti-hepatitis b core total (hbct) instructions for use (ifu), the 95% confidence interval for positive percent agreement is 79.58 ¿ 87.90% for recovered sample so a certain number of false negative results can be expected.Based on the available information, the cause of the discordant result is consistent with normal assay performance.The instrument is fully operational.
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