BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143328 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-29901
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RECEIVED WITH ALL OPERATING CURRENTS WITHIN SPECIFICATION. THE PUMP PASSED THE FUNCTIONAL TESTING INCLUDING THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY AND DISPLACEMENT TESTS. THE PUMP ALSO HAD A CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND BELT CLIP SLOT, AS WELL AS MINOR SCRATCHES ON THE LCD WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS IN THE HOSPITAL, DUE TO A CAR ACCIDENT IN WHICH THE CUSTOMER WAS THE DRIVER AND THE CUSTOMER WAS WEARING THE INSULIN PUMP. IT WAS NOT DETERMINED WHETHER THE ACCIDENT WAS DIABETES RELATED BECAUSE THE CUSTOMER DOES NOT REMEMBER THE ACCIDENT. IT WAS ALSO REPORTED THAT THE FIRE DEPARTMENT DISPOSED OF THE INSULIN PUMP WHILE CLEANING DEBRIS FROM THE ACCIDENT. ADVISED INSULIN PUMP WOULD BE REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603474 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization