BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3941790 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87519
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    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 REPORTED THAT HIS INSULIN PUMP STOPPED WORKING. CUSTOMER'S BLOOD GLUCOSE LEVEL IS 168 MG/DL. CUSTOMER WAS JUST TRAINED IN THE DEVICE. HE REPORTING EXCESSIVE NO DELIVERY ALARMS. HE STATED THAT HE RAN FIVE UNITS OF INSULIN THROUGH THE DEVICE AND IS CURRENTLY DISCONNECTED. WHEN HE DISCONNECTED FROM THE DEVICE, THE CANNULA WAS NOT BENT. CUSTOMER WAS ASSISTED WITH CHANGING HIS INFUSION SET, AND A REPLACEMENT INFUSION SET WAS SENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419767 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR