ABBOTT GMBH ARCHITECT SYPHILIS TP REAGENT KIT; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
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Catalog Number 08D06-32 |
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 12/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This report is being filed on an international product, list number 08d06-32 that has a similar product distributed in the us, list number 08d06-31.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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Event Description
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The customer observed false non-reactive architect syphilis results generated on an architect i1000sr analyzer.Sid (b)(6) initial result on lot 30369be00 = 1.3251 s/co (reactive), repeat result = 1.3459 s/co (reactive) and 0.8070 s/co (nonreactive, from blood bag), repeat results on lot 28074be00 = 1.07 s/co (reactive) and 0.6045 s/co (nonreactive, from blood bag).Sample was processed on another instrument using lot 30369be00 generating a result = 1.3923 s/co (reactive).There was no impact to patient management reported.
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Manufacturer Narrative
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The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record, and inhouse testing of a retained kit with the complaint lot number.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Ticket and trending review did not identify any trends for likely cause lot and complaint issue.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Inhouse testing of a retained reagent kit of lot 28074be00 determined that all specifications were met, and no false non-reactive results were obtained, showing the lots generate the expected results.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency with the architect syphilis tp reagent lot 28074be00 was identified.
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Search Alerts/Recalls
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