BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2499293 · Received March 21, 2012

    Report

    Report Number
    2122870-2012-00829
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 24, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LFX
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. TESTING AT BECKMAN COULTER CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY CONFIRMED RUBELLA IGM REACTIVE RESULTS. HETEROPHILE TESTING WAS ALSO PERFORMED AND RECOVERED NEGATIVE FOR SUBSTANCE INTERFERENCE. PRODUCT LABELING STATES: "THE PRESENCE OF ANTI-RUBELLA IGM DOES NOT ALWAYS INDICATE A RECENT INFECTION, BECAUSE IGM CAN PERSIST FOR MANY MONTHS, OR EVEN FOR SEVERAL YEARS AFTER INFECTION. IGM PRESENCE INDICATES THE NEED FOR QUANTITATIVE EXAMINATION OF ANTI-RUBELLA IGG." QUALITY CONTROL (QC) RECOVERED WITHIN SPECIFICATIONS. THE CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THE CUSTOMER ALLEGED REACTIVE RUBELLA IMMUNOGLOBULIN M (IGM) AND POSITIVE RUBELLA IMMUNOGLOBULIN G (IGG) RESULTS ON TWO DIFFERENT SAMPLES FOR ONE PREGNANT PATIENT INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. SUBSEQUENT TESTING ON TWO ALTERNATE METHODOLOGIES RECOVERED NON-REACTIVE RESULTS. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER SUPPLIED BECKMAN COULTER EUROPE WITH THE PATIENT'S SAMPLES FOR FURTHER ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS RUBELLA IGM| ACCESS RUBELLA IGG