BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2342857 · Received November 18, 2011

    Report

    Report Number
    2122870-2011-05442
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    October 25, 2011
    Report Date
    October 25, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    Z-0607-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED CUSTOMER IN TROUBLESHOOTING. WHEN THE PACK SHARING OCCURS, THE INSTRUMENT DOES NOT DETECT THAT THE PACK TEST COUNT IS INCORRECT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. USE ERROR IS THE ROOT CAUSE FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) TO REPORT A FAILED TROPONIN (ACCUTNI) CALIBRATION. THE ISSUE IS ASSOCIATED WITH THE ACCESS 2 IMMUNOASSAY SYSTEM. IT WAS DETERMINED THE CUSTOMER HAD BEEN SHARING REAGENT PACKS BETWEEN THE TWO ACCESS 2 SYSTEMS. NO PATIENT RESULTS WERE GENERATED OFF THE SHARED REAGENT PACK AS IT WAS A NEW LOT NUMBER AND THE CALIBRATION FAILED. THERE HAVE BEEN NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT IN ASSOCIATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER INC. ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1