BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 3834244 · Received May 28, 2014

    Report

    Report Number
    2122870-2014-00386
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) ADVISED THE CUSTOMER TO CHANGE THE ASPIRATE PROBES AND PERFORM A SPECIAL CLEAN. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE FOUND MICROBUBBLES IN THE WASH PUMP. THE FSE REPLACED THE STATOR AND SEAL OF THE WASH WALVE TO RESOLVE THE ISSUE. (B)(4). ALL ASSOCIATED MDRS: 2122870-2014-00385, 2122870-2014-00387.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULTS FOR FIVE PATIENTS ON AN ACCESS 2 IMMUNOASSAY SYSTEM. THE RESULTS, WHICH WERE ABOVE NORMAL REFERENCE RANGE, WERE RELEASED FROM THE LABORATORY AND QUESTIONED BY THE DOCTORS. THE FIVE PATIENT SAMPLES WERE REPEATED ON THE LABORATORY'S UNICEL DXI INSTRUMENT AND RECOVERED WITHIN NORMAL REFERENCE RANGE. AS A RESULT OF THE ELEVATED TROPONIN RESULTS, THREE OF THE FIVE PATIENTS RECEIVED A CT SCAN. THIS REPORT REFERENCES ONE PATIENT WHOSE TREATMENT WAS AFFECTED; THE PATIENT SAMPLES WERE COLLECTED IN VACCUTAINER TUBES AND CENTRIFUGED FOR FIVE MINUTES AT 3,500 RPM AT 24 DEGREES CELSIUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313125 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other