ROCHE DIAGNOSTICS FREE PSA; TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA
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Catalog Number 03289788190 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).Calibration and qc were acceptable.The customer did not use the required rack adapters for 13 mm diameter tubes.The patient's sample was requested for investigation, but no sample was available at the customer's site.Based on the available data, the investigation did not identify a product problem.The cause of the event could not be determined.
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Event Description
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The initial reporter received questionable free psa and elecsys total psa immunoassay results for one patient tested on a cobas 6000 e 601 module serial number (b)(4).The initial results were reported outside the laboratory.The clinician questioned the results and requested the sample to be repeated for confirmation.On (b)(6) 2020, the initial free psa result was 1.11 ng/ml and the total psa result was 0.746 ng/ml.On (b)(6) 2020, the repeat free psa result was 0.097 ng/ml and the total psa result was 0.511 ng/ml.This medwatch is for free psa.Refer to the medwatch with patient identifier (b)(6) for the total psa assay.
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