BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN PUMP

    MDR report key: 4210530 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43462
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    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 CONCLUSIONS 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 A BLOOD GLUCOSE LEVEL OF 500 MG/DL. THE CUSTOMER TREATED WITH 27 UNITS OF INSULIN BY MANUAL INJECTION. THE CUSTOMER REPORTED THAT HIS INSULIN PUMP WAS NOT FUNCTIONING PROPERLY. WHEN HE CHANGED HIS INFUSION SET, IT STOPPED WORKING MID-PROGRAMMING. HE ATTEMPTED TO CHANGE THE RESERVOIR AND INFUSION SET AND COMPLETE THE REWIND PROCESS, BUT THE INSULIN PUMP DID NOT FUNCTION PROPERLY AND WAS STUCK ON RESERVOIR SETUP. THE INSULIN PUMP GAVE A FAILED BATTERY TEST ALARM. TROUBLESHOOTING WAS DECLINED. THE PRODUCT IS NOT BEING RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680482 INSULIN PUMP OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other