BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2122596 · Received June 14, 2011

    Report

    Report Number
    2122870-2011-01831
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 22, 2011
    Report Date
    May 22, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED ON (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) DETERMINED THAT ASPIRATE PERI-PUMP TUBING, THE WASH STATION DRAIN VALVE, THE SUBSTRATE PROBE, AND THE PRECISION PUMP ASSEMBLY REQUIRED REPLACEMENT AFTER REVIEWING CUSTOMER DATA. AFTER REPAIRS WERE COMPLETED, A SYSTEM CHECK AND QUALITY CONTROL ASSESSMENT WERE EXECUTED WHICH PRODUCED RESULTS WITHIN SPECIFICATIONS. AN ACCUTNI 10 REPLICATE PRECISION RUN WAS ALSO COMPLETED TO DEMONSTRATE THAT THE ACCUTNI ASSAY WAS MEETING PRECISION CLAIMS. ALTHOUGH THE FSE REPLACED SEVERAL HARDWARE COMPONENTS PRIOR TO RETURNING THE INSTRUMENT BACK INTO SERVICE, A DEFINITIVE ROOT CAUSE HAS NOT BEEN IDENTIFIED FOR THIS EVENT TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 CARDIAC TROPONIN (ACCUTNI) RESULTS THAT DID NOT MEET THE PRECISION CLAIMS OF THE ASSAY WAS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM. THE NUMBER OF POTENTIAL DISCREPANT RESULTS IS UNKNOWN. THE CUSTOMER DECLINED TO PROVIDE ANY ADDITIONAL SYSTEM, SAMPLE OR PATIENT RELATED DATA. THE LABORATORY PERFORMS ALL TESTING IN DUPLICATE PRIOR TO RELEASE OUT OF THE LABORATORY. SUSPECT RESULTS ARE RERUN AND ASSESSED FOR VALIDITY PRIOR TO RELEASE. SUSPECT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY, AND THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION IN PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS ACCUTNI REAGENT