BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3841789 · Received May 30, 2014

    Report

    Report Number
    2032227-2014-02720
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    THE CUSTOMER'S MOTHER CALLED TO REPORT THAT CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE LEVELS FOR THE LAST THREE DAYS. CUSTOMER HAD RAISED HER BASAL RATE AND WAS OKAY FOR A LITTLE BIT, BUT THEN STARTED EXPERIENCING HIGH BLOOD GLUCOSE LEVELS AGAIN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 460 MG/DL. SHE HAS TREATED WITH MANUAL INJECTIONS. THE MOTHER ALSO REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM FOR HIGH BLOOD GLUCOSE LEVELS A WEEK AND A HALF AGO. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319594 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization