BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® ACCUTNI?

    MDR report key: 3191766 · Received June 26, 2013

    Report

    Report Number
    2122870-2013-00578
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K021814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THE ACCESS ACCUTNI DEVICE WAS RETURNED FOR EVALUATION. QUALITY CONTROL (QC) DATA WAS WITHIN RANGE. THE CUSTOMER HAD A PASSING SYSTEM CHECK ON (B)(6), 2013. CALIBRATION ALSO PASSED ON (B)(6) 2013 USING REAGENT LOTS 230414 AND 324171. THE FSE NOTED DRIED WASH BUFFER BUILDUP ON THE WASH CAROUSEL. THE FSE CLEANED THE WASH CAROUSEL AND ADJUSTED THE PINCH ROLLER TENSION. THERE IS NO EVIDENCE; HOWEVER, THAT THERE IS AN INSTRUMENT MALFUNCTION. A DEFINITIVE CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING DISCREPANT TROPONIN I (ACCUTNI) PATIENT RESULTS FOR ONE PATIENT, INVOLVING THE ACCESS ACCUTNI ASSAY UTILIZED IN CONJUNCTION WITH THE ACCESS 2 IMMUNOASSAY SYSTEM. THE SAMPLE WAS THREE TIMES ON THE SAME ACCESS 2 ANALYZER (SERIAL NUMBER (B)(4)) AND GENERATED RESULTS OF 0.06, 0.01, AND 0.01 NG/ML. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE FACILITY TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290551 ACCESS® ACCUTNI? IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 230414

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR