BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2073454 · Received May 1, 2011

    Report

    Report Number
    2122870-2011-01195
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT SUPPLIED. SAMPLE COLLECTION, STORAGE, AND CENTRIFUGATION INFORMATION WERE NOT SUPPLIED. SYSTEM CHECK DATA WAS ALSO NOT SUPPLIED. CUSTOMER DID NOT PROVIDE ANY INFORMATION INDICATING INSTRUMENT MALFUNCTION. LAB HAS IMPLEMENTED A REPEAT PROTOCOL ON TROPONIN I RESULTS THAT ARE GREATER THAN 0.50 NG/ML. SERVICE WAS NOT DISPATCHED AS CUSTOMER WAS NOT QUESTIONING INSTRUMENT PERFORMANCE. A CLEAR ROOT CAUSE FOR THIS EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    WHEN CONTACTED BY BECKMAN COULTER INC. (BCI), A CUSTOMER STATED THAT THEIR LABORATORY HAD OBTAINED A FALSE POSITIVE TROPONIN (ACCUTNI) RESULT, GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THIS RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. CUSTOMER WAS UNABLE TO PROVIDE EXACT RESULTS OR DATES OF EVENTS. THERE WAS NO INSTANCE OF DEATH, INJURY, SERIOUS MEDICAL DETERIORATION, OR INAPPROPRIATE MEDICAL TREATMENT DUE TO EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1