BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN PUMP

    MDR report key: 4212021 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-34194
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    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 IS REPORTED THAT A CUSTOMER CALLED TO VERIFY THAT THE PUMP THEY SHIPPED FOR A FAILURE ANALYSIS WOULD RETURN INSTEAD OF THE REPLACEMENT PUMP. THE CUSTOMER ALSO COMPLAINED OF HIGH BLOOD GLUCOSE AT THE TIME OF THE CALL BUT DID NOT WANT TO TROUBLE SHOOT OR GIVE ANYMORE INFORMATION ABOUT THE HIGH BLOOD GLUCOSE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693028 INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR