BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2914580 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-90270
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 30, 2012
    Report Date
    December 30, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ABOVE 400MG/DL. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE READING WAS 95MG/DL BY THE TIME SHE LEFT THE HOSPITAL. HOWEVER, THE NEXT DAY HER BLOOD GLUCOSE DROPPED TO 33MG/DL AND THE LIFE SQUAD WAS CALLED AND TREATED HER BLOOD GLUCOSE WITH AN INSULIN DRIP. TROUBLESHOOTING WAS DECLINED AS CUSTOMER WANTED TO RETURN THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21612 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization