Catalog Number 08057923190 |
Device Problem
Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2024 |
Event Type
malfunction
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Event Description
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There was an allegation of questionable roche diagnostics tina-quant igm gen.2 results for 1 patient on a cobas c 503 analytical unit.The initial result was 38 mg/dl.On (b)(6) 2024 and (b)(6) 2024 the sample was repeated and the results were 13 mg/dl both times.The repeated results are believed to be correct.The sample was initially repeated due to qc being out of specification after the result was obtained.The initial result was reported outside of the laboratory and later corrected.
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Manufacturer Narrative
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The analyzer serial number is (b)(6).The customer refused a field service call.The investigation is ongoing.
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Manufacturer Narrative
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Sections d1-d3, g1, and g4 were updated.The field service representative replaced and adjusted the sample probe.He replaced the piercer and made adjustments.Abnormal aspiration alarms were noted which strongly indicate an insufficient preanalytical handling issue.The qc data show the drift behavior but is within specifications.The analysis shows a module running within specification.
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Search Alerts/Recalls
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