BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1850441 · Received October 1, 2010

    Report

    Report Number
    2122870-2010-00582
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 2, 2010
    Report Date
    October 1, 2010
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES ARE LI HEPARIN PLASMA THAT ARE CENTRIFUGED FOR 5 MINUTES AT 8000 RPM. PER THE CUSTOMER, QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE ERRONEOUS RESULTS. A SYSTEM CHECK WAS PERFORMED ON (B)(6) 2010 AND FAILED THE WASHED %CV OUT HIGH. A FIELD SERVICE ENGINEER WAS DISPATCHED ON (B)(6) 2010: FSE FOUND ASPIRATE PROBE TUBING LOOPED OVER THE POWER MOTOR CABLE FOR THE PIPETTOR. THIS PREVENTED THE PROBE FROM BOTTOMING OUT IN THE CUVET. THE FITTINGS ON THE SUBSTRATE BOTTLE WERE LOOSE, FSE TIGHTENED THEM. FSE REPLACED PERI PUMP TUBING, CLEANED THE WASH VALVE, WASH CAROUSEL AND ASPIRATE PROBES. A SYSTEM CHECK ALONG WITH A PRECISION RUN WITH THE DILUENT ALL MET PUBLISHED SPECIFICATIONS. ALTHOUGH MAINTENANCE AND HARDWARE ISSUES WERE ADDRESSED, NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ACCUTNI RESULTS ABOVE THE AMI CUTOFF AND WITHIN THE RISK STRATIFICATION RANGE FOR 10 PATIENTS' SAMPLES GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. UPON REPEAT ON AN ALTERNATE INSTRUMENT, ALL RESULTS WERE IN THE NORMAL REFERENCE RANGE. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH 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