BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3022120 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-92114
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO KETOACIDOSIS AND HIGH BLOOD GLUCOSE OVER 500MG/DL. THE FATHER STATED THAT THE CUSTOMER CHANGED THE INFUSION SET TWO DAYS PRIOR TO THE EVENT AND THE CANNULA WAS BENT. THE CUSTOMER ALSO CHANGED THE SITE. THE FATHER MENTIONED THAT THE QUICK SERTER WAS STICKING BECAUSE THE ADHESIVE PATCH IS TOO LARGE FOR THE SERTER, WHICH CAUSED TO BEND THE CANNULA AND HER BLOOD GLUCOSE WAS OUT OF CONTROL. THE FATHER STATED THAT SHE INSERTS THE CANNULA IN THE UPPER BUTTOCKS WHILE HE IS NOT STANDING. THE CALLER STATED THAT THE INFUSION SETS WERE TOSSED OUT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123524 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization