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Model Number 06P1601 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Section a1 - patient identifier: sids = (b)(6).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 repeat reactive alinity s anti-hcv ii results for two donors.Since two plasma samples were taken from each donor, the customer performed testing on the second sample which generated nonreactive results.Carryover contamination is suspected as the preceding sample was a reactive sample.The following data was provided: (b)(6) 2023 sid (b)(6): sample 1 initial alinity s anti-hcv ii result = reactive; repeat in duplicate = both reactive, single pcr hcv result = positive.Sample 2 ran in triplicate = all nonreactive for alinity s anti-hcv ii, single pcr hcv result = negative, hcv-lia result = negative.(b)(6) 2023 sid (b)(6): sample 1 initial alinity s anti-hcv ii result = reactive; repeat in duplicate = one reactive, one nonreactive, single pcr hcv result = positive.Sample 2 ran in triplicate = all nonreactive for alinity s anti-hcv ii, single pcr hcv: negative, hcv-lia: negative, no impact to donor management was reported.
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Manufacturer Narrative
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The abbott ambassador performed instrument troubleshooting and q1 system maintenance.In addition, the wash zones were checked and cleaned, and the syringe pump connected to the sample pipettor 1 was replaced.An instrument service history review for (b)(6) did not identify any additional instances of the current issue.A review of the complaints data for the alinity s system revealed no trends or systemic issue associated with the alinity s system nor identified any additional complaints associated with carry-over issues.Additionally, a review of product monitoring review (pmr) metrics identified no trends for the alinity s system or the customer concern as described in this complaint text.The device history record was reviewed and did not identify any non-conformances, potential non-conformances or deviations related to the issue described in the current complaint.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the alinity s system for serial number (b)(6) was identified.
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Event Description
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The customer observed false repeat reactive alinity s anti-hcv ii results for two donors.Since two plasma samples were taken from each donor, the customer performed testing on the second sample which generated nonreactive results.Carryover contamination is suspected as the preceding sample was a reactive sample.The following data was provided: (b)(6) 2023 sid (b)(6): sample 1 initial alinity s anti-hcv ii result = reactive; repeat in duplicate = both reactive single pcr hcv result = positive sample 2 ran in triplicate = all nonreactive for alinity s anti-hcv ii single pcr hcv result = negative hcv-lia result = negative (b)(6) 2023 sid (b)(6): sample 1 initial alinity s anti-hcv ii result = reactive; repeat in duplicate = one reactive, one nonreactive single pcr hcv result = positive sample 2 ran in triplicate = all nonreactive for alinity s anti-hcv ii single pcr hcv: negative hcv-lia: negative no impact to donor management was reported.
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Search Alerts/Recalls
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