BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2964959 · Received February 15, 2013

    Report

    Report Number
    2122870-2013-00075
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 21, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER THAT THE ACCESS 2 IMMUNOASSAY ANALYZER GENERATED AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT OF 4.52 NG/ML, ABOVE THE ACUTE MYOCARDIAL INFARCTION THRESHOLD, FOR ONE PATIENT. FOUR ADDITIONAL SAMPLES WERE COLLECTED FROM THE PATIENT. SUBSEQUENT TESTING ON THESE SAMPLES ON THE SAME INSTRUMENT PRODUCED RESULTS LESS THAN 0.01 NG/ML, WITHIN THE REFERENCE RANGE. THE INITIAL RESULT WAS REPORTED OUT OF THE LABORATORY. THE PATIENT WAS ADMITTED TO CARDIAC CARE UNIT DUE TO THE ELEVATED ACCUTNI RESULT AND SYMPTOMS OF CHEST PAIN. IT IS UNKNOWN IF THERE WERE ANY FURTHER IMPACTS TO PATIENT TREATMENT. THE CUSTOMER PERFORMED PREVENTIVE MAINTENANCE ON THE DAY AFTER THE EVENT, (B)(6) 2013, AND REPLACED MIXER PULLEY. SERVICE WAS DISPATCHED ON (B)(4) 2013. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) DID NOT FIND ANY HARDWARE ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. THE FSE PERFORMED A ROUTINE SYSTEM CHECK AND A HIGH SENSITIVITY SYSTEM CHECK, AND OBTAINED RESULTS WITHIN THE INSTRUMENT PERFORMANCE SPECIFICATIONS. THE CUSTOMER USED THE BELOW REAGENT AND CALIBRATOR FOR TROPONIN ASSAY: ACCESS ACCUTNI REAGENT PACK, CATALOGUE NUMBER A78803, LOT NUMBER 226763; ACCESS ACCUTNI CALIBRATORS, CATALOGUE NUMBER 33345, LOT NUMBER 222575.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66833 ACCESS® 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization