SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2); TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
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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 02/12/2024 |
Event Type
malfunction
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Event Description
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The customer reports observation of a reactive atellica im anti-hepatitis b surface antigen 2 (ahbs2) result which was discordant relative to clinical indications and alternate-method testing.Ahbs2 kit lot 164 was in use at the time.The reactive atellica im ahbs2 result conflicts with a nonreactive/negative ahbs result from an alternate method test.Additionally, elevated reactive hbsii (hepatitis b surface antigen) results are said to indicate that the reactive ahbs2 result is falsely positive.It is indicated that interference by heterophilic antibodies has been excluded.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.
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Manufacturer Narrative
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A customer from outside the united sates reported observation of a reactive (positive) atellica im anti-hepatitis b surface antigen 2 (ahbs2) result which was discordant relative to alternate-method testing.The atellica im ahbs2 instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens is investigating.
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Manufacturer Narrative
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Mdr 1219913-2024-00060 was initially submitted on 06-mar-24.Update, april 2024: siemens has concluded the investigation.A customer from outside the united states reported observation of a reactive atellica im anti-hepatitis b surface antigen 2 (ahbs2) result which was discordant relative to clinical indications and alternate-method testing.Quality control (qc) results were within acceptable ranges, and no issues were observed with any other samples.Assay calibration data did not indicate any issues.On the basis of this information, general reagent issues were ruled out as a likely cause.Service was dispatched to review instrument performance and perform comprehensive instrument maintenance.There were no instrument observations to explain the identified result discordance.There is not sufficient sample material available to permit additional testing.Although a specific cause was not identified, based on the available information, the discordant result may be attributable to a sample-specific interferent.It is noted that other hepatitis assays also produced reactive results which were inconsistent with the patient¿s clinical presentation.The assay¿s instructions for use (ifu) advises the following, under interpretation of results: ¿results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings.¿ no product problem was identified.The customer is operational, and no further action is required.Note: in section h6, codes for investigation findings and investigation conclusions have been updated.
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