BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2132688 · Received June 17, 2011

    Report

    Report Number
    2122870-2011-01871
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, THE CUSTOMER HAD A PASSING SYSTEM CHECK. THE HOTLINE WAS ABLE TO LOCATE THE MISLOADED PSA REAGENT PACK. CUSTOMER UNLOADED AND DISCARDED THE MISLOADED PACK. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE ROOT CAUSE WAS KNOWN USE ERROR IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO RECEIVING ERRONEOUS ELEVATED RECEIVING PSA QC RESULTS OF 0.00 NG/ML ON ALL LEVELS GENERATED BY ACCESS IMMUNOASSAY ANALYZER. PATIENT RESULTS WERE NOT ANALYZED DURING THIS EVENT, THEREFORE NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY., PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1