BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2269847 · Received September 29, 2011

    Report

    Report Number
    2122870-2011-04286
    Event Type
    Malfunction
    Date Received
    September 29, 2011
    Date of Event
    August 31, 2011
    Report Date
    September 2, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN TUBE WITH GEL SEPARATOR, AND WAS CENTRIFUGED AT 6000 RPM FOR 4 MINUTES. QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. HOWEVER, THE ACCUTNI QC RESULTS HAD A QEX FLAG, WHICH MEANS THAT THE QUALITY CONTROL LOT IS EXPIRED. SYSTEM CHECKS ARE PERFORMED WEEKLY AND ALL SPECIFICATIONS HAVE BEEN WITHIN THE RANGES. THERE HAVE BEEN NO FURTHER ISSUES ON ANY OTHER ASSAYS. NO PATIENT SAMPLES WERE RE-RUN AS THE CUSTOMER RE-ANALYZES ANYTHING ABOVE OR EQUAL TO 0.05 NG/ML IN DUPLICATE FOR CONFIRMATION. SERVICE WAS DISPATCHED FOR THIS EVENT AND ON-SITE ON (B)(4) 2011. BEC FIELD SERVICE ENGINEER (FSE) REPLACED ALL THREE ASPIRATE PROBES AND REACTION VESSEL CLIPS. THE FSE RECALIBRATED THE INCUBATOR BELT, AND RAN A SYSTEM CHECK, WHICH FAILED. THE FSE REPLACED PINCH ROLLERS, MIXERS, AND MIXER BELT. THE FSE CLEANED WASH WHEEL AND REACTION VESSEL TRACK. THE FSE PRIMED AND RAN A PASSING SYSTEM CHECK. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER WAS CONTACTED BY BECKMAN COULTER, INC. (BEC) CONCERNING PERFORMANCE OF TROPONIN (ACCUTNI) ASSAYS ON ACCESS 2 IMMUNOASSAY SYSTEM, AND NOTED AN OCCURRENCE OF NON-REPRODUCIBLE FALSE POSITIVE RESULT. THE INITIAL RESULT WAS ABOVE THE AMI CUTOFF AND WAS NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTING ON THE SAME AND ON AN ALTERNATE INSTRUMENT PRODUCED RESULTS WITHIN THE RISK STRATIFICATION RANGE. THE CUSTOMER REPORTED THE CONFIRMED REPEAT RESULT. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1