ABBOTT GMBH ALINITY I SYPHILIS TP REAGENT KIT; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
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Catalog Number 07P60-77 |
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 04/19/2024 |
Event Type
malfunction
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Manufacturer Narrative
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An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available. this report is being filed on an international product, list number 07p60-77, which has a similar product distributed in the us, list number 07p60-21/-31.
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Event Description
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The customer observed a false non-reactive alinity i syphilis tp result generated for a female patient in the dermatology department.The patient presented with ulcerated skin, and at another hospital had a positive result on an unknown platform.The following data was provided (reference range <1 s/co): initial result =0.73 s/co, repeat = 0.76 s/co manual tppa result = positive johnson & johnson result = 5.27s/co (positive) trust result = negative western blot = positive (igm positive, bands were tp15 and tp47) patient was treated with penicillin on the day test results were received due to being in an early stage of syphilis, and treatment was not delayed due to the false non-reactive abbott results.No impact or negative impact to patient management was reported.
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