BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3022981 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-92130
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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

    THE CUSTOMER REPORTED BEING IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 568MG/DL, AND SHE HAD HEART PALPITATIONS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER ATTEMPTED TO CHANGE THE INFUSION SET TWICE AND TREATED WITH MANUAL INJECTIONS, BUT HER BLOOD GLUCOSE WOULD NOT COME DOWN. THE CALLER STATED THAT THE INSULIN PUMP WAS NOT FUNCTIONING PROPERLY AND THE CANNULAS WERE BENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126614 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization