BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3231203 · Received July 17, 2013

    Report

    Report Number
    2032227-2013-02962
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    March 25, 2013
    Report Date
    July 3, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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

    A PHONE CALL WAS MADE TO THE CUSTOMER'S MOTHER IN ORDER TO FOLLOW UP ON A CALL SHE HAD MADE PREVIOUSLY REGARDING HIGH BLOOD GLUCOSE LEVELS. THE MOTHER STATED THAT THE CUSTOMER WAS HOSPITALIZED WITH BLOOD GLUCOSE LEVELS GREATER THAN 600 MG/DL. THE MOTHER STATED THAT SHE WAS LETHARGIC, AND WAS UNABLE TO REGULATE HER BLOOD GLUCOSE LEVELS. THE CUSTOMER ALSO EXPERIENCED VOMITING, DEHYDRATION AND A VIRAL INFECTION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330553 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization