BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON SYSTEMS VANCOMYCIN REAGENT

    MDR report key: 2361410 · Received December 7, 2011

    Report

    Report Number
    2050012-2011-08192
    Event Type
    Malfunction
    Date Received
    December 7, 2011
    Date of Event
    November 7, 2011
    Report Date
    November 7, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LEH
    PMA / PMN Number
    K013076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VANCOMYCIN REAGENT CONTAINS MATERIAL OF ANIMAL ORIGIN AND SHOULD BE CONSIDERED POTENTIALLY INFECTIOUS. THIS REPORT IS ONE OF THREE REPORTS RELATED TO THREE EVENTS THAT OCCURRED ON THE SAME DAY. THIS REPORT IS RELATED TO MDR#2050012-2011-08202 AND MDR#2050012-2011-08203. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT VANCOMYCIN (LOT # M011662) REAGENT CARTRIDGE LEAKED FROM THE BOTTOM SEAM. CUSTOMER WANTED THE VANCOMYCIN REAGENT REPLACED. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON SYSTEMS VANCOMYCIN REAGENT RADIOIMMUNOASSAY, VANCOMYCIN LEH BECKMAN COULTER, INC. M011662

    Patients

    Seq Age Sex Outcome Treatment
    1