BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3873348 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-85781
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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 REPORTED AN ADVERSE EVENT REQUIRING MEDICAL INTERVENTION. CUSTOMER CAME HOME FROM SCHOOL AND HER BLOOD GLUCOSE LEVEL WAS NORMAL. A 15 MINUTES LATER, SHE COMPLAINED ABOUT NOT FEELING WELL AND HER SENSOR GLUCOSE READING WAS 72 MG/DL. CUSTOMER'S MOTHER TREATED THE LOW BLOOD GLUCOSE WITH A SNACK. 15 MINUTES AFTER THAT, CUSTOMER HAD A BLOOD GLUCOSE LEVEL OF 22 MG/DL. PARAMEDICS WERE CALLED AND CUSTOMER WAS TREATED WITH GLUCAGON. CUSTOMER WAS TREATED AT HOME AND NOT ADMITTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349330 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention