BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3844321 · Received June 2, 2014

    Report

    Report Number
    2032227-2014-02853
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 3, 2014
    Report Date
    May 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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

    CUSTOMER REPORTED THAT INITIALLY SHE WENT TO THE EMERGENCY ROOM BECAUSE HER LEG WAS HURTING AND WAS UNABLE TO WALK FOR 26 DAYS. CUSTOMER STATED THAT WHEN SHE GOT TO THE HOSPITAL SHE WAS WITH HIGH BLOOD GLUCOSE AND DKA. CUSTOMER STATED THAT HER BLOOD GLUCOSE WAS 203 MG/DL AT THE TIME OF ADMISSION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321963 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization