BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2244565 · Received September 13, 2011

    Report

    Report Number
    2122870-2011-03398
    Event Type
    Malfunction
    Date Received
    September 13, 2011
    Date of Event
    August 13, 2011
    Report Date
    August 13, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    Z-0607-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WERE NOT PROVIDED. QUALITY CONTROL RESULTS PRIOR TO AND AFTER THE EVENT WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES. HOWEVER, QUALITY CONTROL WAS NOT PERFORMED ON THE MISLOADED REAGENT PACK. USE ERROR IS THE ROOT CAUSE FOR THIS EVENT. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-03752.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING IND/NO VALUE FLAGS AND / OR NORMAL RESULTS FOR TROPONIN (ACCUTNI) ON AN ACCESS 2 IMMUNOASSAY ANALYZER, USED IN CONJUNCTION WITH ACCUTNI REAGENT (LOT 110411). THE NORMAL RESULTS WERE REPORTED OUT OF THE LABORATORY. WHILE TROUBLESHOOTING WITH BECKMAN COULTER (BEC), IT WAS DISCOVERED THAT AN ACCUTNI REAGENT PACK WAS MISLOADED. THE REAGENT PACK WAS IN THE INCORRECT SLOT OF THE REAGENT STORAGE CAROUSEL. WHEN THIS OCCURS THE INSTRUMENT DOES NOT DETECT EITHER A WRONG REAGENT PACK OR NO REAGENT PACK IS PRESENT. REVIEW OF THE DIAGNOSTIC COPY TO DISK DATA INDICATES THREE (3) PATIENT SAMPLES WERE ANALYZED ON THE MISLOADED REAGENT PACK. SUBSEQUENT TESTING ON THE SAME INSTRUMENT WITH A NEW REAGENT PACK PRODUCED AN UNCHANGED RESULT FOR ONE PATIENT AND HIGHER RESULTS FOR TWO PATIENTS. THIS REPORT IS ONE OF TWO AND REPRESENTS THE RESULTS FOR ONE PATIENT WHOSE INITIAL RESULT WAS ERRONEOUSLY LOW AND RERUN RESULT WAS HIGHER. 6. WHILE THERE IS NO REPORT OF ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS UNKNOWN WHETHER THERE WAS A CHANGE TO PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1