BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN PUMP

    MDR report key: 6065270 · Received October 28, 2016

    Report

    Report Number
    2032227-2016-38371
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    September 5, 2016
    Report Date
    October 5, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER ALSO REPORTED THAT THEY WERE HAVING BENT CANNULAS. THE CUSTOMER'S BLOOD GLUCOSE WAS OVER 400 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT THEY TREATED THE HIGH BLOOD GLUCOSE WITH MANUAL INJECTIONS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715060 INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other