BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DSL-10-2000 ACTIVE® CORTISOL ENZYME IMMUNOASSAY (EIA) KIT

    MDR report key: 1416817 · Received July 21, 2009

    Report

    Report Number
    1628193-2009-00001
    Event Type
    Malfunction
    Date Received
    July 21, 2009
    Date of Event
    July 9, 2009
    Report Date
    July 21, 2009
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CGR
    PMA / PMN Number
    K884689
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE OF THE SHIFT IN THE CALIBRATION OF THE ASSIGNED STANDARD VALUES IS CURRENTLY UNDER INVESTIGATION. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    DURING AN INTERNAL TESTING CONDUCTED BY BECKMAN COULTER INC. (BCI), IT WAS REPORTED THAT FALSE HIGH CORTISOL VALUES WERE GENERATED BY THE DSL-10-2000 ACTIVE CORTISOL ENZYME IMMUNOASSAY (EIA) KIT. BECKMAN COULTER HAS CONFIRMED THAT THE FOLLOWING LOT NUMBERS: 04195, 04195A, 04195B, 04195D, 04195E, 04195F, 09266A, 09266, 04126A, 04126, 03066A, 03066, 01036, 716217, 716218, 800408, 800409, 800410, 890929 AND 990168 OF ACTIVE CORTISOL ELISA CALIBRATORS OVER ESTIMATE THE EXPECTED DOSE VALUES FOR PATIENT SERUM SAMPLES DUE TO A SHIFT IN THE ASSIGNED CALIBRATOR VALUES. AN EXAMPLE FOR LOT 990168 WHICH YIELDED VALUES SIGNIFICANTLY ABOVE (2-5X) OTHER PRODUCTS. ALL KITS WITH AFFECTED LOTS RESULTED IN OVERESTIMATION OF CORTISOL DOSE. PATIENT RESULTS WERE NOT GENERATED IN THIS EVENT SINCE THE EVENT WAS DISCOVERED IN-HOUSE AND NO PATIENT SAMPLES WERE TESTED AT THE TIME. THERE WAS NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DSL-10-2000 ACTIVE® CORTISOL ENZYME IMMUNOASSAY (EIA) KIT ACTIVE® CORTISOL EIA, 96 WELLS CGR BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1