BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE STEP PRO 50 TEST STRIPS (2 BOTTLES OF 25 TEST STRIPS)

    MDR report key: 1061856 · Received June 4, 2008

    Report

    Report Number
    MW5007329
    Event Type
    Malfunction
    Date Received
    June 4, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 4, 2008
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    INDIVIDUAL BOTTLES OF 25 TEST STRIPS ARE NOT SEALED. CANNOT TELL IF AN INDIVIDUAL BOTTLE HAS BEEN OPENED ONCE REMOVED FROM SEALED BOX. TWO BOTTLES OF 25 TEST STRIPS EACH ARE PACKAGED IN A SEALED BOX LABELED SURE STEP PRO 50 TEST STRIPS. ONCE THE SEALED BOX IS OPEN, ONE BOTTLE IS USED AT A TIME. LABEL STATES DISCARD 4 MONTHS AFTER OPENING. DIAGNOSIS OR REASON FOR USE: GLYCEMIC CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURE STEP PRO 50 TEST STRIPS (2 BOTTLES OF 25 TEST STRIPS) TEST STRIPS NBW LIFESCAN 2793003008

    Patients

    Seq Age Sex Outcome Treatment
    1