Mdr 1219913-2020-00182, was filed on (b)(6) 2020, for discordant, false reactive (positive) advia centaur xpt anti-hbs2 (ahbs2) results from the same patient.(b)(6) 2020 - additional information: siemens was informed of patient and lot number information that was not previously provided.B7.The patient has an infectious disease and was tested before surgery.The customer was not able to provide any additional patient information.D4.Lot # 118; expiration date 22-mar-2021.H4.Device manufacture date: 22-mar-2019.The patient sample is not available for further testing.The instructions for use (ifu) under the clinical sensitivity and specificity section lists the 95% confidence interval (ci) for resolved relative specificity as 98.34% - 99.88%, thus false positive results can be expected for this assay.Based on the information provided, and a review of internal data, the one false positive patient sample does not indicate a product problem with advia centaur xpt ahbs2 reagent lot 118.The potential cause for the the false positive result observed by the customer is unknown, however pre-analytical factors, a sample issue, or normal assay performance cannot be ruled out.Incident investigation conclusion is pending customer support feedback.Section h6 result code was updated to reflect the additional information.
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Mdr 1219913-2020-00182 was filed on 23-jul-2020 for false reactive (positive) advia centaur xpt anti-hbs2 (ahbs2) results obtained on the same patient.Mdr 1219913-2020-00182 supplemental report 1 was filed on 21-aug-2020 for additional information.25-aug-2020 additional information: siemens has reviewed the event data and has concluded the incident investigation.A review of internal data indicates advia centaur xpt ahbs2 lot 118 is performing as intended and no product problem was identified.Siemens has received customer support feedback and the customer is operational.In summary, the potential cause for the false positive result observed by the customer is unknown, however pre-analytical factors, a sample issue, or normal assay performance cannot be ruled out.The assay is performing within specifications.No further evaluation of the device is required.
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