BECKMAN COULTER ACCESS TESTOSTERONE; RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE
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Model Number 33560 |
Device Problem
High Test Results (2457)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/09/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access testosterone reagent was not returned for evaluation.No hardware errors or issues with other assays were reported in conjunction with this event.Qc was out high and unacceptable at the time of the event and the result was obtained with cex (calibration expired) and clx (calibrator lot expired) flags.Recalibrating with a new reagent pack resolved the issue.Although replacement of reagent pack and recalibrating the assay resolved this issue, the root cause of this event cannot be determined with the available information.The available information reasonably did not suggest a reagent or an instrument malfunction.
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Event Description
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On (b)(6) 2020, the customer reported obtaining a false high testosterone result (access testosterone part number 33560 and lot number 921781) for one patient involving the laboratory's unicel dxi 800 immunoassay analyzer (part number 973100 and serial number (b)(4)).The initial false high access testosterone result of 235.26 ng/dl was obtained on (b)(6) 2020.The result was obtained with cex (calibration expired) and clx (calibrator lot expired) flags.Upon repeat on (b)(6) 2020 on same analyzer with a new reagent pack and new calibration, the result was 21.76 ng/dl which was accordant with the customer expectation.The patient who has an advanced prostate cancer was administered medicine (name not provided by customer) to decrease the testosterone rate based on the erroneous elevated access testosterone result.There was no additional change to or impact to patient care reported in association with this incident.System check passed on 10nov2020.Per customer¿s verbal report, qc was out high and unacceptable at the time of the event.No hardware errors or other assay issues were reported in conjunction with this event.Sample information such as sample collection tube used, centrifugation time and speed, storage or handling was not provided by the customer.
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