BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1903963 · Received November 20, 2010

    Report

    Report Number
    2122870-2010-00789
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE IN LIHEPARIN PLASMA TUBES AND CENTRIFUGED FOR 6 MINUTES AT 5000 RPM. NO SYSTEM CHECK ISSUES OR EVENT ERROR LOGS WERE ASSOCIATED WITH THIS EVENT. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED SYSTEM CHECK AND HIGH SENSITIVITY (HS) SYSTEM CHECK WHICH FAILED. FSE REPLACED THE SAMPLE PIPETTOR AND TRANSDUCER AND ALIGNED THE SYSTEM FSE PERFORMED HS SYSTEM CHECK WHICH MET SPECIFICATIONS. QC WAS PERFORMED AND WAS WITHIN THE CUSTOMERS ESTABLISHED RANGES. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS ERRONEOUS LOW ACCUTNL RESULTS FOR THREE PATIENTS, WHICH DID NOT FIT THEIR CLINICAL PICTURE, GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED ON AN ALTERNATE UNIT AND THE RESULTS WERE ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF AND WITHIN THE RISK STRATIFICATION RANGE. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    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