BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH VERIO STRIPS 100'S

    MDR report key: 8861268 · Received August 2, 2019

    Report

    Report Number
    MW5088750
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    July 23, 2019
    Report Date
    July 23, 2019
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    UDI-DI
    53885027210
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT STATES ABOUT 40 TEST STRIPS OUT OF THE 100 IN THIS LOT GAVE AN ERROR 4 STRIP FII PROBLEM. THE PACKET THAT SWITCHED TO A DIFFERENT LOT OF TEST STRIPS USING THE SAME GLUCOMETER, AND HAD NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648099 ONE TOUCH VERIO STRIPS 100'S SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LIFESCAN, INC. 4463425 53885027210

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR