BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH

    MDR report key: 2751785 · Received September 16, 2012

    Report

    Report Number
    MW5026962
    Event Type
    Injury
    Date Received
    September 16, 2012
    Date of Event
    March 15, 2012
    Report Date
    September 16, 2012
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT IS A TYPE 1 DIABETIC. RECEIVED A ONETOUCH ULTRA MINI METER #SN (B)(4) FROM HIS DOCTOR'S OFFICE IN (B)(6) 2012. GRADUAL SIGNS STARTED - MOOD SWINGS, WEIGHT LOSS, SEVERE CRAMPS, CONFUSION, ETC. SEVERAL VISITS TO DOCTORS AND 3 ER TRIPS. FINALLY 1 ER DOCTOR TESTED HIS METER AND IT WAS SHOWING 147 WHEN IT WAS ACTUALLY 447. PT WAS IN DKA AND LOW POTASSIUM. BOUGHT A DIFFERENT METER AND PT'S HEALTH IS IMPROVING NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ONE TOUCH ULTRA MINI NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization