BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4132198 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31015
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    August 18, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER'S FATHER REPORTED CUSTOMER HAS BEEN HAVING UNEXPLAINED HIGH BLOOD GLUCOSE LEVELS THE LAST FEW WEEKS. CUSTOMER HAS TRIED DIFFERENT INFUSION SETS AND LENGTHS, BUT THE HIGHS PERSIST. CUSTOMER'S BLOOD GLUCOSE WAS 461 MG/DL. HE HAS BEEN TREATING WITH MANUAL INJECTIONS. CUSTOMER EXPERIENCED FEELING THIRSTY AND ILL. IN TROUBLESHOOTING, THE DRIVE SUPPORT CAP APPEARED NORMAL. THERE WAS NO AIR IN THE TUBING. INSULIN EXITED DURING THE MANUAL PRIME. THERE WAS NO LEAK. THE SETTINGS AND HISTORY ARE CORRECT. THE DEVICE PASSED THE HIGH PRESSURE TEST. THE CANNULA WAS NOT BENT. CUSTOMER WAS ADVISED THAT HIGH BLOOD GLUCOSE LEVELS ARE OFTEN CAUSED BY INFUSION SET OR SITE ISSUES. CUSTOMER WAS ADVISED TO DO A COMPLETE SET CHANGE AND MONITOR HIS BLOOD GLUCOSE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613082 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention