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Model Number 6L45-22 |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2022 |
Event Type
malfunction
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Event Description
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The customer reported a physician is questioning elevated total bilirubin results generated on the architect c8000 analyzer on two patients.Results provided: (uom mg/dl) newborn female.(b)(6) 2022 sid (b)(6) = 7.4, ref range [0.0-10.0], (b)(6) 2022 sid (b)(6) = 17.8, ref range [0.0-17.4], (b)(6) 2022 sid (b)(6) = 16.8, ref range [0.0-17.4], (b)(6) 2022 sid (b)(6) results are 13.5, ref range [0.0-13.2], (b)(6) 2022 (b)(6) results are 11.4, ref range [0.0-7.3].Newborn male (b)(6) 2022 sid (b)(6) = 8.7, ref range [0.0-10.0], (b)(6) 2022 sid (b)(6) = 19.3, ref range [0.0-17.4], (b)(6) 2022 sid (b)(6) = 19.5, ref range [0.0-17.4], (b)(6) 2022 sid (b)(6) = 14.1, ref range [0.0-17.4], (b)(6) 2022 sid (b)(6) = 12.5, ref range [0.0-17.4], (b)(6) 2022 sid (b)(6) = 12.0, ref range [0.0-17.4], (b)(6) 2022 sid (b)(6) = 18.8, ref range [0.0-7.3].No impact to patient management was 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.Section a1 patient identifier sids: newborn female, (b)(6) 2022 sid (b)(6), (b)(6) 2022 sid (b)(6), (b)(6) 2022 (b)(6), (b)(6) 2022 (b)(6), (b)(6) 2022 (b)(6).Newborn male: (b)(6) 2022 sid (b)(6), (b)(6) 2022 (b)(6), (b)(6) 2022 (b)(6), (b)(6) 2022 (b)(6), (b)(6) 2022 (b)(6), (b)(6) 2022 (b)(6), (b)(6) 2022 (b)(6).
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Manufacturer Narrative
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A review of tickets determined that there is normal complaint activity for lot 60977uq01.Trending review determined no trends for falsely depressed results for the product.Return testing was not completed as returns were not available.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.The historical performance of reagent lot 60977uq01 was evaluated using world-wide data from abbottlink.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 60977uq01 is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 60977uq01.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no deficiency of the architect total bilirubin reagent lot number 60977uq01 was identified.
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Search Alerts/Recalls
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