BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTISTIX 10 SG URINE DIP STICKS

    MDR report key: 22962609 · Received September 4, 2025

    Report

    Report Number
    22962609
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    July 29, 2025
    Report Date
    August 19, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JIO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN QCING [QUALITY CONTROLLING] URINE STRIPS THEY FAILED THE TEST. FOR NITRATE AND LEVEL CONTROL 1 AND IT TESTED POSITIVE ON 3 STRIPS. ALL OTHER BOXES OF STRIPS THAT WERE QCED THAT DAY AND FROM THE SAME LOT NUMBER PASSED WITHOUT AN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1473928 MULTISTIX 10 SG URINE DIP STICKS BLOOD, OCCULT, COLORIMETRIC, IN URINE JIO SIEMENS HEALTHCARE DIAGNOSTICS INC. 409016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male