Model Number SYPHILIS |
Device Problem
False Negative Result (1225)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred in (b)(6).Calibration signals were acceptable, however, the last calibration was performed on (b)(6) 2020.Qc results were acceptable.The investigation is ongoing.
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Event Description
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The initial reporter complained of questionable (b)(6) results for 1 patient sample tested for elecsys (b)(6) on a cobas 6000 e 601 module.The patient had unsafe sexual intercourse."the foreskin of the patient¿s glans flaky erosion for a week and there are some macula on the patient¿s back.Patient will have a pain at sometimes." the patient went to the doctor based on these symptoms and the following results were obtained: the initial result from the e601 module was (b)(6).The sample was repeated on the same e601 module with a result of (b)(6).The sample was repeated on a different e601 module at a different site with results of (b)(6).The sample was tested by the trust method and the result was "(b)(6)." no specific result was provided.The sample was tested by the abbott method with a result of (b)(6).The roche results were reported outside of the laboratory.The e601 module serial number was (b)(4).The serial number for the other e601 module was not provided.
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Manufacturer Narrative
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The patient sample was not available for investigation.During a review of the alarm trace data, no relevant alarms were observed.The reagent performs within specification as calibration and qc were within the specified ranges.Product labeling states: "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 investigation did not identify a product problem.The cause of the event could not be determined.
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Search Alerts/Recalls
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