BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTISTIX 10SG STRIPS

    MDR report key: 3535810 · Received November 22, 2013

    Report

    Report Number
    1217157-2013-00222
    Event Type
    Other
    Date Received
    November 22, 2013
    Date of Event
    September 15, 2013
    Report Date
    November 1, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE BOTTLE OF THE MULTISTIX 10 SG FROM THE CUSTOMER WAS RETURNED FOR INVESTIGATION. NO SAMPLE FROM THE PT WAS PROVIDED. SIEMENS TECHNICAL OPERATIONS COMPLETED THEIR TESTING BUT WERE UNABLE TO CONFIRM THE CUSTOMERS OBSERVATIONS. THE CAUSE FOR THE DISCORDANT WHITE BLOOD CELL RESULT IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 1+ TO 2+ WHITE BLOOD CELL RESULTS ON THE MULTISTIX STRIP VISUALLY WHEREAS MICROSCOPIC RESULT WAS LARGE FOR THE WHITE BLOOD CELLS. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610396 MULTISTIX 10SG STRIPS MULTISTIX 10SG JIO SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1