BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STROMATOLYSER-IM (SIM-220A)

    MDR report key: 1840808 · Received September 10, 2010

    Report

    Report Number
    1840808
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    July 6, 2009
    Report Date
    December 29, 2009
    Manufacturer
    SYSMEX AMERICA
    Product Code
    GGK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    SYSMEX DISCOVERED SEVEN LOTS OF SIM-220A MANUFACTURED BETWEEN 3/3/09 AND 3/26/09 THAT TESTED POSITIVE FOR A PSEUDOMONAS TYPE SPECIES OF BACTERIA. LAB MANAGER DISCARDED LOTS AND SYSMEX REPLACED ORDER.====================== MANUFACTURER RESPONSE FOR LAB REAGENTS, STROMATOLYSER-IM (SIM-220A)======================MANUFACTURER ADVISED TO DISCARD REMAINING REGEANTS AND NEW LOT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STROMATOLYSER-IM (SIM-220A) LAB REAGENTS GGK SYSMEX AMERICA * C9010, 11, 13, 14, 15, 16, 17

    Patients

    Seq Age Sex Outcome Treatment
    1 *