BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4233414 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-49200
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    November 3, 2014
    Report Date
    November 3, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 589 MG/DL. THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER REPORTED THAT SHE HAD AN INFECTION THAT WAS CAUSING HER BLOOD GLUCOSE LEVELS TO RISE. THE CUSTOMER REPORTED TRYING TO TREAT HERSELF WITH THE INSULIN PUMP AND A MANUAL INJECTION BUT HER BLOOD GLUCOSE LEVELS WOULD NOT GO DOWN. THE CUSTOMER REPORTED GOING TO THE HOSPITAL AND WAS GIVEN ANOTHER TEN UNITS OF INSULIN INTRAVENOUSLY. IT WAS REPORTED THAT THE BLOOD GLUCOSE LEVELS OF THE CUSTOMER WENT DOWN EVENTUALLY HITTING A LOW BLOOD GLUCOSE LEVEL OF 45 MG/DL AND CONTINUED TO DROP. THE CUSTOMER REPORTED GOING INTO A FULL SEIZURE. THE CUSTOMER WAS RELEASED FROM THE HOSPITAL AFTER ASKING TO BE RELEASED. THE CUSTOMER DECLINED ANY TROUBLESHOOTING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712619 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization