BEUDAMED
    FDA Adverse Event Summary report: N

    SYNCHRON VANCOMYCIN REAGENT

    MDR report key: 2120807 · Received June 10, 2011

    Report

    Report Number
    2050012-2011-02256
    Date Received
    June 10, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LEH
    PMA / PMN Number
    K013076
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CHANGE (B)(6). FROM: SYNCHRON UNICEL DXC 600, TO: SYNCHRON VANCOMYCIN REAGENT. FROM: CLINICAL CHEMISTRY ANALYZER, TO: SYNCHRON VANCOMYCIN REAGENT. CLASSIFICATION CODE: FROM: JJE, TO: LEH. FROM: K042291, TO: K013076.

    Additional Manufacturer Narrative · 1

    CREDIT MEMO WAS ISSUED.

    Description of Event or Problem · 1

    BECKMAN COULTER INC. (BCI) TAIWAN REPORTED THE VANCOMYCIN REAGENT CARTRIDGE WAS CHIPPED AT THE SEAM AND LEAKED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON VANCOMYCIN REAGENT SYNCHRON VANCOMYCIN REAGENT LEH BECKMAN COULTER INC. VANC 200 M010684

    Patients

    Seq Age Sex Outcome Treatment
    1