BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3854953 · Received June 9, 2014

    Report

    Report Number
    2032227-2014-02952
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED BY THE DIABETES EDUCATOR THAT THEY HAD A PATIENT WHO WAS HOSPITALIZED. THE CALLER WANTED TO VERIFY WHETHER THE INSULIN PUMP WAS FUNCTIONING PROPERLY OR NOT. THE MEDTRONIC REPRESENTATIVE PROVIDED ASSISTANCE AND IT WAS DETERMINED THAT THERE WAS NOTHING WRONG WITH THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336095 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization