ABBOTT GMBH ALINITY I ANTI-HCV REAGENT KIT; ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS
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Catalog Number 08P06-74 |
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 09/28/2022 |
Event Type
malfunction
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Event Description
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The customer observed a false nonreactive alinity i anti-hcv results for one patient.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): initial result was 0.86, repeat, after recalibration and re-centrifuging, was 0.96 s/co.The sample was tested with a maccura assay, and the result was 9.88 s/co.The sample was also tested with a roche assay and the result was 51.2 s/co.There was no impact to patient management reported.
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Manufacturer Narrative
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An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.Phone complete entry = (b)(6).This report is being filed on an international product, list number 08p06-74, that has a similar product distributed in the us, list number 08p05.
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Manufacturer Narrative
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Section a1 - patient identifier complete entry = patient 1, sample id (b)(6), sample id (b)(6), sample id (b)(6), and sample id (b)(6) all available patient information was included.Additional patient details are not available.Additional patient data provided by the customer was added to section b5 - describe event or problem.The complaint investigation for false nonreactive alinity i anti-hcv results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and testing of the complaint lot number.Trending review determined no related trend for the issue for the product.Return testing was not completed, as returns were not available.Sensitivity testing was performed using an in-house retained kit of lot 36107be01, stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.In addition, the clinical sensitivity of the lot was evaluated by testing two commercially available seroconversion panels (zeptometrix hcv 9047 and hcv 9045).The seroconversion panel results were compared to historical architect anti-hcv test results provided by zeptometrix, since architect anti-hcv and alinity i anti-hcv assays are equivalent.The lot detected the same bleeds as reactive for the seroconversion panels.Based on these data it was shown that the sensitivity performance of the complaint lot is not adversely affected.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity i anti-hcv reagent, lot number 36107be01, was identified.
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Event Description
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The customer observed false nonreactive alinity i anti-hcv results for five patients.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): patient 1 initial result, on (b)(6) 2022, was 0.86, repeat, after recalibration and re-centrifuging, was 0.96 s/co.The sample was tested with a maccura assay, and the result was 9.88 s/co.The sample was also tested with a roche assay and the result was 51.2 s/co.The following patient data was provided by the customer on 20oct2022: sample id (b)(6) initial result was 0.52, repeats were 0.56 and 0.56 s/co, repeat with a maccura assay was 5.053 s/co, which is reactive.Sample id (b)(6) initial result was 0.82, repeats were 0.76 and 0.73 s/co, repeat with a maccura assay was 2.737 s/co, which is reactive.Sample id (b)(6) initial result was 0.77, repeats were 0.83 and 0.69 s/co, repeat with a maccura assay was 16.321 s/co, which is reactive.Sample id (b)(6) initial result was 0.71, repeats were 0.63 and 0.65 s/co, repeat with a maccura assay was 7.914 s/co, which is reactive.There was no impact to patient management reported.
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