BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4183115 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40128
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    August 27, 2014
    Report Date
    October 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 THEY HAD A BENT CANNULA THAT CAUSED A BLOOD GLUCOSE LEVEL OF 1100 MG/DL. THE CUSTOMER STATED THAT THEY WERE SUPPOSE TO RECEIVE SURGERY, BUT THE BENT CANNULA WAS FOUND WHICH REQUIRED THEM TO SEND HER TO A (B)(6) HOSPITAL. THE CUSTOMER WAS IN THE EMERGENCY ROOM FOR HER HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER WAS WEARING THE PUMP WHILE SHE WAS IN THE EMERGENCY ROOM. THE CUSTOMER LEFT THE HOSPITAL BEFORE BEING TREATED BY A HEALTH CARE PROFESSIONAL BECAUSE OF THE WAITING TIME. THE CUSTOMER DECLINED TROUBLESHOOTING. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660706 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization