BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2022867 · Received March 17, 2011

    Report

    Report Number
    2122870-2011-00625
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE DATA AND CENTRIFUGATION INFORMATION WAS NOT SUPPLIED. CUSTOMER DID NOT PROVIDE QC OR SYSTEM CHECK DATA. CUSTOMER HAS IMPLEMENTED A RERUN PROTOCOL FOR EVERY TROPONIN (ACCUTNI) TEST TO INSURE REPRODUCIBILITY OF RESULTS BEFORE REPORTING OUTSIDE THE LABORATORY. SERVICE WAS NOT DISPATCHED, AS CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE. NO CLEAR ROOT CAUSE HAS BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    BECKMAN COULTER INC., (BCI) CONTACTED THIS CUSTOMER VIA THE TROPONIN (ACCUTNI) MARKETING SURVEY PROGRAM (MSP) CUSTOMER CONTACT PROGRAM. THE CUSTOMER INDICATED SOME OCCURRENCES OF NON-REPRODUCIBLE FALSE POSITIVE ACCUTNI PATIENT RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER WAS UNABLE TO PROVIDE THE EXACT RESULTS OR DATES OF EVENTS. CUSTOMER STATED THAT THERE WAS NO INSTANCE OF DEATH, INJURY, SERIOUS MEDICAL DETERIORATION, OR INAPPROPRIATE MEDICAL TREATMENT DUE TO THE ERRONEOUS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1