BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP MMT

    MDR report key: 3854454 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-85294
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    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

    THE CUSTOMER'S FATHER REPORTED THE CUSTOMER'S HIGH BLOOD GLUCOSE LEVEL OF 500 MG/DL. THE PATIENT'S SYMPTOMS WERE LOW AND TRACE KETONES. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. AT THE TIME OF THE REPORT, THE INSULIN PUMP WAS ALARMING NO DELIVERY. TROUBLESHOOTING WAS PERFORMED AND IT WAS STATED THAT THE CANNULA WAS BENT AND OCCLUDED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332102 530G INSULIN PUMP MMT OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR