BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2508237 · Received March 28, 2012

    Report

    Report Number
    2122870-2012-00870
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Date of Event
    March 7, 2012
    Report Date
    March 8, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    2050012-08/19/2010-030C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER INC. SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. THROUGH BECKMAN COULTER INC. TROUBLESHOOTING IT WAS IDENTIFIED THAT USE ERROR, IN THE FORM OF PACK SHARING, HAD OCCURRED. (B)(4). A PREVIOUS BECKMAN COULTER INC. CUSTOMER NOTIFICATION HAD BEEN ISSUED IN RELATION TO THIS ISSUE. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2012-00868, 2122870-2012-00869, 2122870-2012-00870, 2122870-2012-00871.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBSERVING PACK MONITORING ERRORS FOR BR MONITOR, DEHYDROEPIANDROSTERONE SULFATE (DHEAS), ESTRADIOL AND GI MONITOR ON THEIR UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM. NO PATIENT RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THIS REPORT REPRESENTS THE ISSUES SURROUNDING THE ESTRADIOL REAGENT. AS PART OF ISSUE TROUBLESHOOTING, THE BECKMAN COULTER INC. REPRESENTATIVE ADVISED THE CUSTOMER TO REMOVE THE REAGENT PACK AND LOAD IT ONTO ANOTHER INSTRUMENT TO SEE IF THE INSTRUMENT 'ACKNOWLEDGED' THE REAGENT PACK SERIAL NUMBER. THE ALTERNATE INSTRUMENT ACKNOWLEDGED THIS SPECIFIC REAGENT PACK AND INDICATED A "USED" TEST COUNT FOR THE PACK. THIS CONFIRMED THAT THE REAGENT PACK HAVE BEEN PREVIOUSLY LOADED AND UTILIZED ON THE ALTERNATE INSTRUMENT, AND HENCE PACK SHARING HAD OCCURRED. BECKMAN COULTER INC. LABELING INDICATES THAT PACK SHARING SHOULD NOT OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS ESTRADIOL REAGENT