BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML

    MDR report key: 4143011 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-29953
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OF 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 OUT KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS IN THE HOSP FOR A TOE REMOVAL, AND WHILE THERE HE WAS GIVEN AN INSULIN PUMP. IT WAS ALSO REPORTED THAT THE CUSTOMER RECEIVED A NO DELIVERY ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME 315MG/DL. TROUBLESHOOTING OCCURRED. CUSTOMER WAS INFORMED THAT THE NO DELIVERY ALARM WAS CAUSED BY RESERVOIR OCCLUSION. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603512 RESERVOIR 3ML FRN MEDTRONIC MINIMED MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR