BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2979123 · Received February 26, 2013

    Report

    Report Number
    2122870-2013-00130
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER COMPLAINT INVESTIGATOR REVIEWED THE QUALITY CONTROL DATA PROVIDED BY THE CUSTOMER AND NOTED THAT THE CUSTOMER WAS OBTAINING ACCEPTABLE QUALITY CONTROL RESULTS FOR ALL LEVELS THROUGHOUT THE PERIOD BETWEEN (B)(6) 2013. THE COMPLAINT INVESTIGATOR ALSO REVIEWED THE RESULTS OF CALIBRATION AND SYSTEM CHECK PERFORMED ON (B)(6) 2013, RESPECTIVELY, AND NOTED ALL RESULTS WERE ACCEPTABLE. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE ON (B)(4) 2013 AND INSPECTED THE ANALYZER. THE FSE NOTED AIR BUBBLES IN THE ANALYZER'S WASH PUMP AND CLEANED THE WASH VALVE TO RESOLVE THE ISSUE. THE FSE ATTRIBUTED THE ERRATIC ACCUTNI RESULTS TO THE AIR BUBBLES IN THE WASH PUMP. A RELATED EVENT ON (B)(6) 2013 AT THE CUSTOMER'S SITE IS DOCUMENTED IN MDR #2122870-2013-00131.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER THAT THE ACCESS 2 IMMUNOASSAY ANALYZER GENERATED ERRONEOUS TROPONIN (ACCUTNI) RESULTS, IN RISK STRATIFICATION RANGE, FOR THREE PATIENTS. THE RESULTS FOR TWO OF THE PATIENTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN AS THE RESULTS DID NOT MATCH THE CLINICAL PRESENTATION OF THE PATIENTS. REPEAT TESTING WAS NOT PERFORMED ON THESE TWO PATIENT SAMPLES AS THE SAMPLES HAD BEEN STORED AT ROOM TEMPERATURE FOR TOO LONG. THE THIRD PATIENT'S SAMPLE WAS RE-TESTED ON THE SAME INSTRUMENT AND PRODUCED A RESULT OUTSIDE THE ASSAY'S PRECISION CLAIM OF 8.0%. THE RESULTS FOR THE THIRD PATIENT WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT IN CONNECTION TO THIS EVENT. THE CUSTOMER USED THE BELOW REAGENT AND CALIBRATOR FOR TROPONIN ASSAY: ACCESS ACCUTNI REAGENT PACK, CATALOGUE NUMBER A78803, LOT NUMBER 226762; ACCESS ACCUTNI CALIBRATORS, CATALOGUE NUMBER 33345, LOT NUMBER 222575.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82722 ACCESS® 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1