BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS TESTOSTERONE

    MDR report key: 11054740 · Received December 22, 2020

    Report

    Report Number
    2122870-2020-00097
    Event Type
    Injury
    Date Received
    December 22, 2020
    Date of Event
    December 9, 2020
    Report Date
    December 22, 2020
    Manufacturer
    BECKMAN COULTER
    Product Code
    CDZ
    UDI-DI
    15099590231347
    PMA / PMN Number
    K001935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521141 ACCESS TESTOSTERONE RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE CDZ BECKMAN COULTER 33560 921781 15099590231347

    Patients

    Seq Age Sex Outcome Treatment
    1 Other