BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3990220 · Received August 7, 2014

    Report

    Report Number
    3004209178-2014-91190
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED HER SON'S INSULIN PUMP RAN OUT OF INSULIN AND DID NOT ALARM THAT IT WAS EMPTY. CUSTOMER ALSO REPORTED MULTIPLE LOST SENSOR AND WEAK SIGNAL ALARMS. CUSTOMER'S BLOOD GLUCOSE IS 452 MG/DL. THE DEVICE DID NOT ALARM TO THE EMPTY RESERVOIRS BECAUSE THE SETTING WAS TURNED OFF. CUSTOMER HAS SINCE TURNED THE SETTING ON. CUSTOMER'S MOTHER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE WEAK SIGNAL AND LOST SENSOR ALERTS WERE MOST LIKELY DUE TO RADIO FREQUENCY INTERFERENCE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464505 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention