BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4221842 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46883
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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 THE CUSTOMER RECEIVED A NO DELIVERY ALARM DURING A BOLUS. THE CUSTOMER'S BLOOD GLUCOSE WAS 469 MG/DL. TROUBLESHOOTING FOUND INSULIN WAS ABLE TO EXIT DURING A FIXED PRIME. THE CUSTOMER ALSO STATED SHE WAS UNABLE TO REMOVE THE INFUSION SET AND EXAMINE THE CANNULA AT THE TIME OF THE CALL. THE CUSTOMER WAS ADVISED TO CHANGE OUT THEIR INFUSION SET. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701276 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR