BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO® SYNCHRON CLINICAL SYSTEM

    MDR report key: 2110789 · Received June 1, 2011

    Report

    Report Number
    2050012-2011-02070
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WERE NOT PROVIDED. QC WAS OUT LOW BY 2 SD ON (B)(6) 2011 WITH NO ACTION TAKEN. QC WAS WITHIN ESTABLISHED RANGES BEFORE THE EVENT. BCI HOTLINE SENT THE CUSTOMER ENVIRONMENTAL CAPS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THAT THE UNICEL DXC 600 PRO INSTRUMENT GENERATED ERRONEOUSLY LOW TOTAL PROTEIN (TP) RESULTS FOR NINE (9) PATIENTS. RESULTS WERE REPORTED OUT OF THE LAB. REPEAT TESTING GENERATED HIGHER RESULTS AND PATIENT REPORTS WERE AMENDED. NO CHANGE TO PATIENT TREATMENT OR DIAGNOSIS WAS REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO® SYNCHRON CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR