BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4173736 · Received October 15, 2014

    Report

    Report Number
    2032227-2014-38353
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 14, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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

    IT IS REPORTED THAT A CUSTOMER WAS HOSPITALIZED FOR A TICK BITE AND HIGH BLOOD GLUCOSE LEVEL OF 590 MG/DL. THE CUSTOMER STATED THEY WERE OFF PUMP THERAPY FOR 8 HOURS BEFORE THE AMBULANCE CAME. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH MANUAL INJECTIONS. THE CUSTOMER IS UNSURE IF THEY WANT TO SEND THE RESERVOIR BACK FOR ANALYSIS NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655946 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR