BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA STRP BLUE 100

    MDR report key: 2932271 · Received January 21, 2013

    Report

    Report Number
    MW5028725
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    LIFESCAN
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PER PATIENT, THE STRIPS ARE DEFECTIVE AND WOULD GIVE NO READING EXCEPT AN ERROR MESSAGE, 7 OUT OF THE 25 STRIPS, OUT OF 100 TOTAL COUNT. DEFECTIVE BATCH FOR THE ONE TOUCH ULTRA STRP BLUE 100 PERHAPS. DOSE, FREQUENCY AND ROUTE USED: USE 4 TIMES A DAY. THERAPY DATES: (B)(6) /2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28845 ONE TOUCH ULTRA STRP BLUE 100 NONE NBW LIFESCAN 3371791

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR