BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3854813 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-85476
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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

    THE CUSTOMER REPORTED THAT HIS INSULIN PUMP TRAINER DOWNLOADED HIS READINGS AND IT WAS SHOWING CARB ENTRIES THE CUSTOMER DENIED ENTERING. THE CUSTOMER STATED THAT HE DID NOT OVERRIDE AND HE ONLY ENTERED HIS CARBS. THE CUSTOMER MENTIONED THAT THE INCIDENT IT HAPPENS EVERY DAY AND WITHIN A MINUTE OF EACH OTHER. THE CUSTOMER DID NOT FEEL COMFORTABLE WEARING THE INSULIN PUMP WITH THIS ISSUE GOING ON; HE TOOK OFF THE DEVICE AND PUT HIM BACK ON HIS OLD INSULIN PUMP FOR THE MOMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332946 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR