BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 1914674 · Received December 3, 2010

    Report

    Report Number
    2122870-2010-00858
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE TROUBLESHOOTING WITH A BCI CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS DISCOVERED THAT NO REAGENT PACK WAS PRESENT IN THE DESIGNATED SLOT IN THE REAGENT STORAGE CAROUSEL. THE CTS ASSISTED THE CUSTOMER IN REMOVING THE MISS-LOADED REAGENT PACK AND VERIFYING THE REMAINING ONBOARD REAGENT INVENTORY. USER ERROR IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO 0.00 IU/ML AND NO VALUE IND* FLAGGED THYROID STIMULATING HORMONE (HTSH) RESULTS GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER FOR FOUR PATIENTS. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT. * IND = INDETERMINATE. THE RESULT IS AT THE LOW END OF THE ANALYTICAL RANGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1