BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA MINI METER

    MDR report key: 3212628 · Received July 5, 2013

    Report

    Report Number
    MW5030774
    Event Type
    Injury
    Date Received
    July 5, 2013
    Report Date
    July 5, 2013
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS THAT, SHE BOUGHT A ONE TOUCH ULTRA MINI METER FROM (B)(6) PHARMACY. SHE REPORTS THE DEVICE ITSELF IS NOT THE ISSUE BUT THE PHARMACY. THE PHARMACY RESTOCKED A RETURNED DEVICE WITHOUT APPROPRIATELY CHECKING TO MAKE SURE IT HAD NOT BEEN USED BY THE PREVIOUS PURCHASER. WHEN SHE BOUGHT THE DEVICE, WENT HOME AND TRIED TO USE IT, SHE WAS POKED TWICE BY A NEEDLE ALREADY IN THE DEVICE. THIS DEVICE HAD PREVIOUSLY BEEN USED AND THE NEEDLE WAS FORGOTTEN IN IT. SHE RUSHED TO THE EMERGENCY ROOM AND HAD SOME BLOOD WORK DONE. REPORTER IS (B)(6) PREGNANT AND SHE IS VERY CONCERNED ABOUT HER SAFETY AND THE SAFETY OF HER UNBORN CHILD. SHE CONTACTED (B)(6) WHICH AFTER SOME INVESTIGATION REALIZED THEY WERE AT FAULT. THEY CREATED AN INCIDENT REPORT AND SAID THERE WAS NOTHING ELSE THEY COULD DO FOR HER. WHILE SHE AWAITS THE LAB RESULTS, SHE PLEADS WITH THE FDA TO DO MORE AND HELP PROTECT THE PUBLIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308304 ONE TOUCH ULTRA MINI METER NONE NBW JOHNSON & JOHNSON R1209194X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other