BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3895440 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-86155
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    CUSTOMER'S MOTHER CALLED REGARDING THE ALLERGIC REACTION TO THE INSULIN. THE INSULIN CLOGS UP THE INSULIN PUMP. THE CUSTOMER HAS BEEN EXPERIENCING HIGH BLOOD GLUCOSE. CUSTOMER HAS BEEN SICK. THE BLOOD GLUCOSE READING HAVE BEEN HIGH IN THE 500 RANGE. CUSTOMER WAS TAKEN TO THE HOSPITAL TO GET THE BLOOD GLUCOSE LEVELS UNDER CONTROL. CUSTOMER ALSO EXPERIENCED DIABETES KETOACIDOSIS; THE BLOOD GLUCOSE READING WAS 600 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370020 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization