BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2111029 · Received June 2, 2011

    Report

    Report Number
    2122870-2011-01660
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN IDENTIFIED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER WAS EXPERIENCING POOR PERFORMANCE OF QUALITY CONTROL (QC) RESULTS FOR THE PROGESTERONE ASSAY ON A UNICEL DXL 600 ACCESS IMMUNOASSAY SYSTEM. QUALITY CONTROL RESULTS ASSOCIATED WITH A SPECIFIC REAGENT LOT HAD SHIFTED DOWN TWO TO THREE STANDARD DEVIATIONS FROM MEAN AND POSSESSED %CVS (%COEFFICIENT OF VARIATION) ON ALL THREE QC LEVELS THAT WERE NOT UNACCEPTABLE TO THE CUSTOMER. THE CUSTOMER CHANGED TO A NEW REAGENT LOT. SUBSEQUENT LEVEL ONE QC RESULTS WERE RECOVERING AT MEAN VALUE. DATA PROVIDED BY THE CUSTOMER INDICATES THE GENERATION OF TWO PROGESTERONE VALUES FOR TWO PATIENT SAMPLES THAT DIFFERED BETWEEN THE INITIAL VALUE AND THE REPEAT VALUE. SAMPLE NUMBER ONE'S INITIAL AND REPEAT RESULTS WERE GENERATED FROM THE SAME INSTRUMENT BUT USING DIFFERENT REAGENT LOTS. SAMPLE NUMBER TWO'S INITIAL AND REPEAT RESULTS WERE GENERATED FROM DIFFERENT INSTRUMENTS. THE SECOND INSTRUMENT IS UNKNOWN. THE INITIAL RESULTS WERE RELEASED FROM THE LABORATORY HOWEVER THERE WAS NO REPORTED DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS PROGESTERONE