BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3121173 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-93766
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OVER 400MG/DL. TROUBLESHOOTING WAS PERFORMED. THE MOTHER STATED THAT THE CUSTOMER HAD INCREASED INSULIN A COUPLE MONTHS AGO, BECAUSE HIS BLOOD GLUCOSE HAD BEEN RUNNING HIGH. IT WAS MENTIONED THAT THE CUSTOMER HAD STREP THROAT AND BROUGHT DOWN HIS GLUCOSE LEVEL TO 284MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222827 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization