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Model Number 6L45-42 |
Device Problem
Low Test Results (2458)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/15/2023 |
Event Type
malfunction
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Event Description
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The customer observed falsely decreased architect total bilirubin results for multiple samples when running on the architect c8000 processing module.The following sids were provided by the customer that generated initial results of < 0.1 mg/dl since (b)(6) 2023.The qc run right after and determined level 1 was out of range low and was not repeated.Level 1 qc once again was out of range low on (b)(6) 2023.All patient samples were re-tested on another architect c8000 and generated results within normal range.The customer immediately sent out corrected reports.The following repeat testing results were: patient repeat results (unit of measure: mg/dl) (b)(6) = 0.2, (b)(6) = 0.3, (b)(6) = 0.3, (b)(6) = 0.3, (b)(6) = 0.3, (b)(6) = 0.5, (b)(6) = 0.4, (b)(6)= 0.4, (b)(6) = 0.3, (b)(6) = 0.3.The customer¿s normal range for total bilirubin is 0.2-1.5 mg/dl.Through troubleshooting, the customer opened fresh calibrator, recalibrated the assay and ran qc.The qc is now on the mean for levels 1, 3, and the pediatric.No repeat testing on the analyzer after troubleshooting tasks were performed were provided by the customer.There was no impact to patient management reported.
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Manufacturer Narrative
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Patient identifier: (b)(6).All available patient information is included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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Manufacturer Narrative
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The complaint investigation for falsely depressed total bilirubin results when calibrated with bilirubin calibrator on architect c 8000 processing module included a search for similar complaints, and the review of complaint text, trending data, labeling, field data, and device history records.Return testing was not performed as returns were not available.The lot search did not find abnormal complaint activity for lot 61824uq03 and lot 37197fd01.Trending review determined no related trends for the products for the issue.Review of the device history records did not identify any issue related to the current complaint for total bilirubin reagent lot 61824uq03 and bilirubin calibrator lot 37197fd01.The historical performance of reagent lot 61824uq03 was evaluated using world-wide data from customers in the field.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 61824uq03 is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 61824uq03.Review of labeling adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for architect total bilirubin reagent lot 61824uq03 and bilirubin calibrator lot 37197fd01.
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Event Description
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The customer observed falsely decreased architect total bilirubin results for multiple samples when running on the architect c8000 processing module.The following sids were provided by the customer that generated initial results of < 0.1 mg/dl since (b)(6)2023.The qc run right after and determined level 1 was out of range low and was not repeated.Level 1 qc once again was out of range low on 16jan2023.All patient samples were re-tested on another architect c8000 and generated results within normal range.The customer immediately sent out corrected reports.The following repeat testing results were: patient repeat results (unit of measure: mg/dl) (b)(6)= 0.2; (b)(6)= 0.3; (b)(6)= 0.3; (b)(6)= 0.3; (b)(6)= 0.3; (b)(6)= 0.5; (b)(6)= 0.4; (b)(6)= 0.4; (b)(6)= 0.3; (b)(6)= 0.3.The customer¿s normal range for total bilirubin is 0.2-1.5 mg/dl.Through troubleshooting, the customer opened fresh calibrator, recalibrated the assay and ran qc.The qc is now on the mean for levels 1, 3, and the pediatric.No repeat testing on the analyzer after troubleshooting tasks were performed were provided by the customer.There was no impact to patient management reported.
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Search Alerts/Recalls
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