Catalog Number 04404483190 |
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 06/27/2023 |
Event Type
malfunction
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Event Description
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The initial reporter questioned the results for 4 patient samples tested with a particular reagent lot for gluc3 glucose hk (gluc3 ) on a cobas integra 400 plus.The results with reagent lot 625672 were higher than the repeat results with reagent lot 698268.Patient 1 initial result was 132.5 mg/dl.The repeat result was 84.8 mg/dl.Patient 2 initial result was 133.3 mg/dl.The repeat result was 89.9mg/dl.Patient 3 initial result was 132.5 mg/dl.The repeat result was 84.8 mg/dl.Patient 4 initial result was 153.7 mg/dl.The repeat result was 111.2 mg/dl.
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Manufacturer Narrative
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The integra 400 plus serial number was (b)(6).The customer had no further issues after replacing the reagent pack.Calibration was acceptable.The qc data provided showed imprecision.Maintenance data indicate several maintenance actions are overdue.Several "clot detection" and "no fluid detection" alarms were observed on the alarm trace data.These alarms suggest pre-analytic issues.The investigation is ongoing.
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Manufacturer Narrative
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Calibration data was within specifications.Quality control data showed imprecision.Several maintenance actions were observed to be overdue.Upon review of the alarm trace, no fluid detected and clot detected alarms were observed.The investigation determined the issue is consistent with incorrect pre-analytic sample handling and missed customer maintenance.
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Search Alerts/Recalls
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