BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2142333 · Received June 20, 2011

    Report

    Report Number
    2032227-2011-01507
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS TAKEN TO THE HOSPITAL TODAY FOR HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER AND HIS WIFE ARE BOTH UNABLE TO TROUBLESHOOT OVER THE PHONE. THE CALLER STATED THAT THE CUSTOMER SUFFERS FROM DEMENTIA, AND DOES NOT UNDERSTAND THE INSULIN PUMP VERY WELL. THE CALLED STATED THAT SHE IS PLANNING ON TAKING THE CUSTOMER OFF OF INSULIN PUMP THERAPY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization