BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS HYBRITECH PSA

    MDR report key: 2535781 · Received April 15, 2012

    Report

    Report Number
    2122870-2012-01071
    Event Type
    Malfunction
    Date Received
    April 15, 2012
    Date of Event
    March 25, 2012
    Report Date
    March 27, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LTJ
    PMA / PMN Number
    K974816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012 CUSTOMER REPORTED THAT THEY OBTAINED 0.00 NG/ML HYB-PSA RESULTS FOR 35 PATIENTS ON THE ACCESS 2 ANALYZER. CUSTOMER STATED THAT THE PATIENTS HAD OTHER ASSAYS PERFORMED ON THEIR SAMPLES (SUCH AS TSH) AND THE HYB-PSA ASSAY WAS THE ONLY ONE THAT PRODUCED THIS TYPE OF RESULT. PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THEREFORE, PATIENT RESULTS AND PATIENT TREATMENT WERE NOT AFFECTED. CUSTOMER STATED THAT THEY WENT TO OFF-LOAD THE HYB-PSA REAGENT PACK AND DISCOVERED THAT THERE WAS NO PACK PRESENT IN THE SELECTED REAGENT CAROUSEL SLOT. CUSTOMER ALSO STATED THAT THERE WAS NO CHANGE TO PATIENT CARE DUE TO THE 0.00 NG/ML HYB-PSA PREVIOUSLY REPORTED. SERVICE WAS NOT DISPATCHED AS IT WAS CONCLUDED THAT THE LABORATORY'S TECHNICIAN HAD INCORRECTLY LOADED A HYB-PSA REAGENT PACK IN THE INCORRECT REAGENT CAROUSEL SLOT ON THE ANALYZER. ROOT CAUSE OF THE EVENT WAS USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS HYBRITECH PSA TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTAT LTJ BECKMAN COULTER, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1