BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU5421-02 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 1840521 · Received September 21, 2010

    Report

    Report Number
    2050012-2010-00829
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 21, 2010
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K011720
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS IN LAB'S CONTROL RANGE OF +/-20%. CALIBRATION FACTORS CONFIRM SHIFT IN QC SAME AS SHIFT IN TP CALIBRATION FACTOR. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO COPY REACTION MONITOR DATA FOR QC SAMPLES AND PRINT OUT QC AND CALIBRATION INFORMATION. ROOT CAUSE WAS CONFIRMED TO BE PRE-ANALYTICAL - CALIBRATION PREPARATION ERROR ALONG WITH INAPPROPRIATE CONTROL RANGES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSELY ELEVATED SERUM TOTAL PROTEIN (TP) RESULTS GENERATED BY THE AU5421-02 CLINICAL CHEMISTRY ANALYZER. THE PATIENT SAMPLES WERE RELEASED WITH 0.3 TO 0.7G/DL ELEVATED TP RESULTS (APPROXIMATELY +15%) FOR 3 DAYS FROM (B)(6) 2010 TO (B)(6) 2010 FOR ABOUT 1400 PATIENTS. THERE IS NO POTENTIAL HARM. PER CUSTOMER, THE SIGNIFICANT INCREASE WOULD BE RECOGNIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU5421-02 CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1