BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2580217 · Received May 18, 2012

    Report

    Report Number
    2122870-2012-01340
    Event Type
    Malfunction
    Date Received
    May 18, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 1, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. THE INSTRUMENT WAS EVALUATED VIA BECKMAN COULTER INC. CUSTOMER TECHNICAL SPECIALIST (CTS) TROUBLESHOOTING. UPON COMPLETION OF SUCCESSFUL BECKMAN COULTER INC. TROUBLESHOOTING, THE INSTRUMENT WAS RETURNED BACK INTO SERVICE. BECKMAN COULTER INC. ACCESS 2 OPERATOR GUIDE INSTRUCTS THE HEALTHCARE WORKER TO PHYSICALLY REMOVE THE REAGENT PACK PRIOR TO COMPLETING THE INSTRUMENT ENTRIES WHICH REMOVE THE PACK FROM THE INSTRUMENT'S SUPPLY SCREEN. THE CAUSE OF THE MISLOADED REAGENT PACK WAS USE ERROR. THE CUSTOMER DID NOT FOLLOW BECKMAN COULTER LABELING WHEN REMOVING THE REAGENT PACK THEREBY CAUSING THE INSTRUMENT TO IDENTIFY THE PACK AS UNLOADED BEFORE IT PHYSICALLY WAS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO PHYSICALLY UNLOAD A SPECIFIC CARDIAC TROPONIN (ACCUTNI) REAGENT PACK FROM AN ACCESS 2 IMMUNOASSAY SYSTEM BECAUSE THEY HAD NOT CORRECTLY RECORDED THE UNLOAD OF THE REAGENT PACK ON THE INSTRUMENT AND HENCE THE SYSTEM BELIEVED THAT THE PACK WAS ALREADY UNLOADED, WHEN IN FACT THE REAGENT PACK WAS STILL PHYSICALLY PRESENT ON THE INSTRUMENT. THERE WERE NO PATIENT RESULTS GENERATED AS PART OF THIS EVENT. THE BECKMAN COULTER INC. CUSTOMER TECHNICAL SPECIALIST (CTS) IDENTIFIED THAT THE ACCUTNI REAGENT PACK IDENTIFIED AS "UNLOADED" BY THE INSTRUMENT WAS STILL ONBOARD IN SLOT ONE ON THE REAGENT CAROUSEL. THE CTS LED THE CUSTOMER THROUGH INSTRUMENT TROUBLESHOOTING AND SUCCESSFULLY PHYSICALLY REMOVED THE REAGENT PACK FROM THE INSTRUMENT. THE REAGENT LOT ASSOCIATED WITH THIS EVENT WAS 121411.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1