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Model Number 3L80-22 |
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 07/22/2021 |
Event Type
malfunction
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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.The complaint investigation was performed for observed false elevated carbon dioxide results which included a search for similar complaints, and review of the complaint text, trending data, labeling, device history records, and historical performance of reagent lot 58854uq01 through worldwide data.A review of tickets determined there is normal complaint activity for lot number 58854uq01.Trending review determined no trends identified for the product related to the issue.Return testing was not completed as returns were not available.Historical performance was reviewed using worldwide data and determined that the patient median result for carbon dioxide reagent lot number 58854uq01 is within established control limits.The device history record was reviewed and determined no non-conformances or deviations related to the complaint.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or deficiency of carbon dioxide reagent lot number 58854uq01 was identified.
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Event Description
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The customer observed falsely elevated carbon dioxide (co2) results for 8 patients while running on the architect c4000 analyzer.The customer investigated further after discovering high patient co2 results and decided to run qc to verify that the controls were still in range even though the daily qc was performed and in range for that morning.The qc generated values out of range on all three levels of control.The customer removed the old pack with 18 tests left and loaded a new reagent kit of the same lot number and calibrated the kit on the analyzer.The customer ran qc and it was in range for the new reagent kit.The samples were then repeated on the same analyzer with the following data provided (customer¿s normal range: 18-30 mmol/l): sid (b)(6) = initial = 33 mmol/l, repeat = 24 mmol/l.Sid (b)(6) = initial = 39 mmol/l, repeat = 31 mmol/l.Sid (b)(6) = initial = 43 mmol/l, repeat = 30 mmol/l.Sid (b)(6) = initial = 36 mmol/l, repeat = 25 mmol/l.Sid (b)(6) = initial = 39 mmol/l, repeat = 26 mmol/l.Sid (b)(6) = initial = 35 mmol/l, repeat = 24 mmol/l.Sid (b)(6) = initial = 34 mmol/l, repeat = 21 mmol/l.Sid (b)(6) = initial = 41 mmol/l, repeat = 24 mmol/l.There was no impact to patient management reported.
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Search Alerts/Recalls
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