Catalog Number 05795397190 |
Device Problem
Non Reproducible Results (4029)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The country of origin is (b)(6).The most recent qc had acceptable results.The investigation is ongoing.
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Event Description
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The initial reporter received questionable bilt3 bilirubin total gen.3 results from the cobas integra 400 plus serial number (b)(4).The initial bilirubin total result was 0.906 mg/dl the repeat results using a 1:2 dilution was 0.85 mg/dl and a 1:1 dilution was 0.91 mg/dl.A bilimeter manufactured by fa.Pfaff result was 3.3 mg/dl and radiometer abl 90 flex result was 2.8 mg/dl.The newly drawn sample on (b)(6) 2021 result was 1.042 mg/dl.The bilimeter manufactured by fa.Pfaff result was 3.5 mg/dl.The customer expected a higher value due to a suspected diagnosis of anorexia and due to the color of the sample as it was more yellow than normal.The questionable results were reported outside the laboratory.
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Manufacturer Narrative
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The samples from the patient were provided for investigation.The results obtained by the customer could be reproduced.Further investigations of the samples could not find any interfering factors.A general reagent problem can be ruled out because calibration and quality control are acceptable.The investigation did not identify a product problem.The cause of the event could not be determined.
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Search Alerts/Recalls
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