BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 2388674 · Received December 16, 2011

    Report

    Report Number
    MW5023543
    Event Type
    Malfunction
    Date Received
    December 16, 2011
    Date of Event
    December 16, 2011
    Report Date
    December 16, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    INSULIN PUMP WENT OFF WARRANTY (B)(6) 2011. THERE IS DIMINISHED BATTERY LIFE, SCRATCHES ON THE CASING, ACT BUTTONS SOMETIMES NEED TO BE PUSHED MORE THAN ONCE AND PUMP IS MAKING GRINDING NOISES WHEN REWINDING. DATES OF USE: (B)(6) 2007 - (B)(6) 2011. DIAGNOSIS OR REASON FOR USE: DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED PARADIGM 522 LZG MEDTRONIC MINIMED PARADIGM 522 PARADIGM 522

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR