BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3873218 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-85623
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    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 STATED THAT HER DAUGHTER HAS BEEN EXPERIENCING HIGH BLOOD GLUCOSE FOR TWO WEEKS. THE PHYSICIAN HAS BEEN CONTACTED AND NOTHING IS WORKING. CUSTOMER IS USING THE SENSOR. THE BLOOD GLUCOSE READING IS 414 MG/DL. CUSTOMER IS EXPERIENCING FREQUENT URINATION, THIRST AND FATIGUE. CUSTOMER TREATED WITH INSULIN PUMP. THE PHYSICIAN HAS RAISED THE BASAL RAISES. DURING TROUBLESHOOTING, THERE WERE A LOT OF HOLD SUSPENDS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349097 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR