BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2930868 · Received January 28, 2013

    Report

    Report Number
    2122870-2013-00049
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 5, 2013
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ROTOR. REAGENTS USED IN CONJUNCTION WITH THE ACCESS 2 IMMUNOASSAY ANALYZER: ACCESS ACCUTNI CALIBRATOR, LOT NUMBER 222575. ACCESS ACCUTNI 2 X 50 DETERMINATIONS, LOT NUMBER 226763.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. THAT THE ACCESS 2 IMMUNOASSAY ANALYZER (ACCESS 2) GENERATED TWO TROPONIN I (ACCUTNI) RESULTS THAT WERE ABOVE THE ACUTE MYOCARDIAL INFARCTION CUTOFF VALUE. ONE ELEVATED RESULT WAS REPORTED OUT OF THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT. CUSTOMER REPORTED THEY RETESTED THE SAMPLES AND THE REPEATED RESULTS WERE WITHIN THE NORMAL RANGE. CUSTOMER INDICATED THERE WAS NO CHANGE IN PATIENT TREATMENT. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE TO EVALUATE THE INSTRUMENT. THE FSE FOUND THE ROTOR WAS LOOSE ON THE SHAFT CAUSING BUBBLES IN THE WASH PUMP. THE FSE REPLACED THE WASH VALVE ASSEMBLY. THE FSE ALSO PERFORMED PREVENTIVE MAINTENANCE. THE FSE PERFORMED SYSTEM VERIFICATION PROCEDURES AFTER THE REPAIRS. THE SYSTEM VERIFICATION PROCEDURES PASSED WITHIN THE ASSAY SPECIFICATIONS AND THE INSTRUMENT SPECIFICATIONS FOLLOWING SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36849 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1