BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTISTIX 8 SG

    MDR report key: 3163073 · Received May 10, 2013

    Report

    Report Number
    1217157-2013-00076
    Event Type
    Other
    Date Received
    May 10, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 22, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JIO
    PMA / PMN Number
    K905396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISCORDANT RESULTS WERE DUE TO OPERATOR ERROR. SIEMENS INVESTIGATION FOUND THAT THE SITE WAS USING A NON-SIEMENS INSTRUMENT TO READ THE SIEMENS MULTISTIX 8SG STRIPS. AS STATED IN THE MULTISTIX 8SG IFU: SIEMENS REAGENT STRIPS ARE READY TO USE UPON REMOVAL FROM THE BOTTLE AND THE ENTIRE REAGENT STRIP IS DISPOSABLE. THE STRIPS MAY BE READ VISUALLY, REQUIRING NO ADDITIONAL LABORATORY EQUIPMENT FOR TESTING. THE STRIPS CAN ALSO BE READ INSTRUMENTALLY, USING THE CLINITEK FAMILY OF URINE CHEMISTRY ANALYZERS AND THE APPROPRIATE SOFTWARE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE NEGATIVE RESULTS FOR LEUKOCYTES ON MULTISTIX 8SG STRIPS. THERE WAS NO REPORT OF INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209458 MULTISTIX 8 SG MULTISTIX 8 SG JIO SIEMENS HEALTHCARE DIAGNOSTICS INC. 207056

    Patients

    Seq Age Sex Outcome Treatment
    1