BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4241227 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50081
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED NEEDING ASSISTANCE PROGRAMMING HER REPLACEMENT INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 32 MG/DL. SHE TREATED WITH A PIECE OF CAKE. CUSTOMER WAS ADVISED TO SPEAK TO HER DOCTOR REGARDING ADJUSTMENTS TO HER SETTINGS. CUSTOMER WAS ASSISTED WITH SETTING UP HER BOLUS WIZARD. CUSTOMER DECLINED TROUBLESHOOTING FOR LOW BLOOD GLUCOSE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723844 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention