BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3120989 · Received May 20, 2013

    Report

    Report Number
    2032227-2013-02000
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT THE DRIVE SUPPORT CAP WAS PROTRUDING. THE REPORTED BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 106 MG/DL. ADVISED THE CUSTOMER THAT THE INSULIN PUMP NEEDS TO BE REPLACED. HOWEVER, THE CUSTOMER DECLINED AS SHE HAS NO INSURANCE AT THIS TIME. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222241 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR