BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4183567 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40338
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 121 MG/DL. THE CUSTOMER REPORTED A NO DELIVERY ALARM FROM THE INSULIN PUMP. TROUBLESHOOTING WAS DONE. THE CUSTOMER REPORTED THAT THE CANNULA WAS NOT BENT. THE CUSTOMER REPORTED THAT THE INSULIN EXITED THE CANNULA. THE CUSTOMER WAS ADVISED THAT THE INFUSION SITE MAY BE OCCLUDED. THE CUSTOMER ALSO REPORTED A LITTLE RED MARK BY THE INFUSION SITE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663960 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR