BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2182663 · Received July 28, 2011

    Report

    Report Number
    2122870-2011-02546
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011, AN ERRONEOUS, LOW TOTAL THYROXINE (TT4) RESULT, WITHIN THE NORMAL REFERENCE RANGE, WAS GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT SAMPLE. UPON REPEAT ON ANOTHER LABORATORY'S INSTRUMENT, THE TT4 RESULT WAS HIGHER, ABOVE THE NORMAL REFERENCE RANGE, AND CONSIDERED VALID. THE INITIAL ERRONEOUS TT4 RESULT WAS NOT REPORTED OUT OF THE LABORATORY, AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. SYSTEM CHECK RESULTS GENERATED PRIOR TO THE EVENT MET ESTABLISHED SPECIFICATIONS. HOWEVER, INSTRUMENT TT4 QUALITY CONTROL RESULTS DID NOT RECOVER WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THE TIMEFRAME OF THIS EVENT. THE SAMPLES WERE RUN WITHIN ONE TO TWO HOURS OF EACH OTHER. SAMPLES WERE TRANSPORTED BETWEEN LABORATORIES IN ALIQUOT TUBES. SAMPLES WERE REFRIGERATED DURING TRANSPORT. SPECIFIC PATIENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS TOTAL T4 REAGENT