Model Number SYPHILIS E2G |
Device Problem
Low Test Results (2458)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/07/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation determined that the calibration and qc were acceptable.The investigation is ongoing.The event occurred in (b)(6).
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Event Description
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The initial reporter complained of questionable results for 1 patient tested for syphilis elecsys on a cobas 8000 e 801 module serial number (b)(4) compared the pcr method.The initial syphilis result was (b)(6) and the pcr treponema pallidum result was (b)(6).A new sample was collected.On (b)(6) 2019 the syphilis result for the new sample was (b)(6) and the pcr treponema pallidum result was (b)(6).The (b)(6) syphilis result was reported outside of the laboratory.The physician questioned the result.There was no allegation of an adverse event.
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Manufacturer Narrative
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The customer provided two samples for investigation.The samples were non-reactive for elecsys syphilis assay and all non-treponemal assays but reactive when tested using the competitor¿s treponemal assays.In this investigation the specific igm antigens showed reactivity with the first sample, while the igg- specific antigens remain non-reactive.The second draw shows an increase in igm reactivity and a slight increase in one igg specific-antigen.These findings indicate the possibility of an early phase of syphilis infection.The package insert addresses the possibility of a false non-reactive results: "a negative test result does not completely rule out the possibility of an infection with treponema pallidum.Serum or plasma samples from the very early (pre-seroconversion) phase or the late phase of a syphilis infection can occasionally yield negative findings." the reagent performs within specification.
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Search Alerts/Recalls
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