BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2311590 · Received October 27, 2011

    Report

    Report Number
    2122870-2011-04896
    Event Type
    Malfunction
    Date Received
    October 27, 2011
    Date of Event
    September 27, 2011
    Report Date
    September 27, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    2050012-08/19/2010-030C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE LIKELY ROOT CAUSE WAS DISCOVERED WHILE TROUBLESHOOTING WITH CTS. USE ERROR IS THE ROOT CAUSE OF THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED THAT THEY OBTAINED NO VALUE INDETERMINED (IND), FLAGGED ALPHA-FETOPROTEIN (AFP) QC RESULTS. THE INSTRUMENT ASSOCIATED WITH THIS EVENT IS ACCESS 2 IMMUNOASSAY SYSTEM. WHILE TROUBLESHOOTING WITH HOTLINE IT WAS DISCOVERED THAT AN AFP REAGENT PACK HAD NOT BEEN PROPERLY LOADED IN THE DESIGNATED SLOT ON THE REAGENT STORAGE CAROUSEL BY THE CUSTOMER. A CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER IN REMOVING THE MISPLACED REAGENT PACK AND VERIFYING PROPER PACK PLACEMENT FOR THE REMAINDER OF THE ON BOARD REAGENT PACKS. THE CUSTOMER STATED TO CTS THAT ALL OTHER ASSAY QC WAS PASSING. THE CUSTOMER IS NOT QUESTIONING ANY PATIENT RESULTS AS ONLY QC WAS PERFORMED AT THE TIME OF THE EVENT. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED 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 JJE BECKMAN COULTER INC. ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1