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Catalog Number 08P07-22 |
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 01/06/2023 |
Event Type
malfunction
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Event Description
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The customer observed false nonreactive alinity i hiv ag/ab combo result for one donor sample.Three days after the donation, the patient had a medical checkup for symptoms of influenza and hiv was among the tests performed which turned out to be reactive.The customer sent the original sample to another blood bank that utilized the roche platform, and the result was nonreactive.A confirmatory test was also ordered, and the result was positive.The following data was provided: (b)(6) 2023 sid 12300107 alinity initial result = nonreactive; roche result = 0.212 (nonreactive) (b)(6) 2023 result from medical checkup = reactive.Confirmatory test result = positive.On (b)(6) 2023, the customer provided clarification on the data.(b)(6) 2023 sdi 12300107 alinity initial result = 0.081 s/co (nonreactive).(b)(6) 2023 sid 12300107 alinity repeat result = 0.074 s/co (nonreactive).No impact to donor management was reported.
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Manufacturer Narrative
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This issue was previously reported under mdr number 3016438761-2023-00186-01 under a different suspect device.This report is being filed on an international product, alinity i hiv ag/ab combo, list number 08p07-22, that has a similar product distributed in the us, list number 08p07-21/-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 nonreactive alinity i hiv ag/ab combo result for one donor sample.Three days after the donation, the patient had a medical checkup for symptoms of influenza and hiv was among the tests performed which turned out to be reactive.The customer sent the original sample to another blood bank that utilized the roche platform, and the result was nonreactive.A confirmatory test was also ordered, and the result was positive.The following data was provided: (b)(6) 2023 sid (b)(6) alinity initial result = nonreactive; roche result = 0.212 (nonreactive).(b)(6) 2023 result from medical checkup = reactive.Confirmatory test result = positive.On (b)(6) 2023, the customer provided clarification on the data.(b)(6) 2023 sdi (b)(6) alinity initial result = 0.081 s/co (nonreactive).(b)(6) 2023 sid (b)(6) alinity repeat result = 0.074 s/co (nonreactive).No impact to donor management was reported.
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Manufacturer Narrative
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The complaint investigation for false nonreactive alinity i hiv ag/ab combo results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.In-house testing of retained reagent kit was also completed.Return testing was not performed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.However, data were inconclusive as the roche technique also provided a negative result.Ticket search by lot indicates that the reagent lots perform as expected for this product.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot numbers 42104be00, 47210be00 and complaint issue.Labeling was reviewed and found to be adequate.In-house testing of a retained reagent kit of the complaint lots was performed, and specifications were met which indicates the product is performing as expected.In addition, the clinical sensitivity was evaluated by testing two commercially available seroconversion panels (zeptometrix hiv 9013 and hiv 9016).The seroconversion panel results were compared to hiv test results provided by zeptometrix and the reagent lots detected the same bleeds as reactive for the seroconversion panels.Based on these data, it showed that the sensitivity performance of the complaint lots is not adversely affected.Based on our investigation, no systemic issue or deficiency was identified with the alinity i hiv ag/ab combo reagent for lots 42104be00 and 47210be00.
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Event Description
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The customer observed false nonreactive alinity i hiv ag/ab combo result for one donor sample.Three days after the donation, the patient had a medical checkup for symptoms of influenza and hiv was among the tests performed which turned out to be reactive.The customer sent the original sample to another blood bank that utilized the roche platform, and the result was nonreactive.A confirmatory test was also ordered, and the result was positive.The following data was provided: (b)(6) 2023 sid (b)(6) alinity initial result = nonreactive; roche result = 0.212 (nonreactive) (b)(6) 2023 result from medical checkup = reactive.Confirmatory test result = positive.On (b)(6) 2023, the customer provided clarification on the data.(b)(6) 2023 sdi (b)(6) alinity initial result = 0.081 s/co (nonreactive).(b)(6) 2023 sid (b)(6) alinity repeat result = 0.074 s/co (nonreactive).No impact to donor management was reported.
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Manufacturer Narrative
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The complaint investigation for false nonreactive alinity i hiv ag/ab combo results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.In-house testing of retained reagent kit was also completed.Return testing was not performed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.However, data were inconclusive as the roche technique also provided a negative result.Ticket search by lot indicates that the reagent lots perform as expected for this product.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot number 47210be00 and complaint issue.Labeling was reviewed and found to be adequate.In-house testing of a retained reagent kit of the complaint lot was performed, and specifications were met which indicates the product is performing as expected.In addition, the clinical sensitivity was evaluated by testing two commercially available seroconversion panels (zeptometrix hiv 9013 and hiv 9016).The seroconversion panel results were compared to hiv test results provided by zeptometrix and the reagent lots detected the same bleeds as reactive for the seroconversion panels.Based on these data, it showed that the sensitivity performance of the complaint lot is not adversely affected.Based on our investigation, no systemic issue or deficiency was identified with the alinity i hiv ag/ab combo reagent for lot 47210be00.This follow-up includes a correction of clerical error to h10 - additional mfg narrative.The complaint investigation was for complaint lot number 47210be00.
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Manufacturer Narrative
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Update: additional information section h6 - adverse event problem, type of investigation- additional b codes provided which were not on the previous submission.
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Event Description
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The customer observed false nonreactive alinity i hiv ag/ab combo result for one donor sample.Three days after the donation, the patient had a medical checkup for symptoms of influenza and hiv was among the tests performed which turned out to be reactive.The customer sent the original sample to another blood bank that utilized the roche platform, and the result was nonreactive.A confirmatory test was also ordered, and the result was positive.The following data was provided: (b)(6) 2023 sid (b)(6) alinity initial result = nonreactive; roche result = 0.212 (nonreactive) (b)(6) 2023 result from medical checkup = reactive.Confirmatory test result = positive.On (b)(6) 2023, the customer provided clarification on the data.(b)(6) 2023 sdi (b)(6) alinity initial result = 0.081 s/co (nonreactive).(b)(6) 2023 sid (b)(6) alinity repeat result = 0.074 s/co (nonreactive).No impact to donor management was reported.
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Search Alerts/Recalls
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