BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2060340 · Received April 16, 2011

    Report

    Report Number
    2122870-2011-00965
    Event Type
    Malfunction
    Date Received
    April 16, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DISCOVERED WHILE TROUBLESHOOTING WITH BCI HOTLINE THAT A CKMB REAGENT PACK WAS MISLOADED AND THEREFORE IN THE INCORRECT SLOT OF THE REAGENT STORAGE CAROUSEL. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE ROOT CAUSE WAS IDENTIFIED WHILE TROUBLESHOOTING WITH HOTLINE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING IND/NO VALUE FLAGS FOR CKMB RESULTS ON 2 PATIENT SAMPLES GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. UPON REPEAT ON AN ALTERNATE METHODOLOGY, RESULTS OF 1.4NG/ML AND 0.8NG/ML WERE OBTAINED FOR THE 2 PATIENTS RESPECTIVELY. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1