BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2180403 · Received July 27, 2011

    Report

    Report Number
    2122870-2011-02466
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL SAMPLES WITH ACCUTNI RESULTS GREATER THAN 0.06NG/ML ARE RE-CENTRIFUGES AND RE-ANALYZED. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THIS EVENT. PER THE CF, SYSTEM CHECKS HAVE BEEN WITHIN SPECIFICATIONS. MYOGLOBIN AND TBHCG ARE ALSO ANALYZED ON THIS INSTRUMENT AND THERE HAVE BEEN NO ISSUES WITH THESE ASSAYS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011. THE FSE FOUND THE HIGH VOLTAGE SETTING CHANGED FROM 176 TO 197. THE FSE REPLACED THE TRANSDUCER HOUSING AND VERIFIED THE ALIGNMENTS AND SETTINGS. ALL VERIFICATION TESTING MET SPECIFICATIONS. NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED THAT THEY OBTAINED A TROPONIN (ACCUTNI) RESULT WITHIN THE RISK STRATIFICATION RANGE FOR ONE (1) PATIENT'S SAMPLE. THE SPECIMEN WAS ANALYZED ON ACCESS 2 IMMUNOASSAY SYSTEM. UPON REPEAT, THE RESULT WAS WITHIN THE NORMAL REFERENCE RANGE. THE RESULTS WERE REPORTED OUT OF THE LAB. CUSTOMER STATES THE PATIENTS WERE HELD LONGER FOR OBSERVATION ONLY, NO ADDITIONAL TREATMENT WAS PURSUED. NO FURTHER 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 JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1