BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1994165 · Received February 16, 2011

    Report

    Report Number
    2122870-2011-00429
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JLB
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WAS NOT SUPPLIED. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE ERRONEOUS RESULTS. AFTER THE ERRONEOUS RESULTS QC WAS OUT OF SPECIFICATIONS HIGH. CUSTOMER TECHNICAL SUPPORT (CTS) HAD THE CUSTOMER CHECK THE REAGENT COOLER TEMP AND IT WAS OUT OF SPECIFICATIONS HIGH. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FSE ADJUSTED THE ALIGNMENT OF THE MAIN PIPETTOR TO THE REAGENT PACK. THE FSE ALSO REPLACED THE PELTIER AND THE THERMISTORS. THE FSE ALSO REBUILT THE WASH PUMP AND THE PRECISION PUMP ROTOR AND THE HOME SENSOR WERE REPLACED. ALL VERIFICATION TESTING MET SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING CREATININE KINASE - MB (CK-MB) RESULTS ABOVE THE NORMAL REFERENCE RANGE THAT WERE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER, UPON REPEAT TESTING ON AN ALTERNATE INSTRUMENT RESULTED IN A LOWER CLINICAL CATEGORY. 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 JLB BECKMAN COULTER INC. ACCESS® 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1