BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2990684 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-91603
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    October 3, 2012
    Report Date
    February 22, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 LOW BLOOD GLUCOSE OVER 40MG/DL. THE CALLER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS IN A VEHICLE ACCIDENT AND SHE WAS THE DRIVER. THE CALLER STATED THAT SHE HAD STARTED TAKING A MEDICATION AND HER DOCTOR HAD DROPPED THE DOSAGE CONSIDERABLY, WHICH MAY HAVE CAUSED HER BLOOD GLUCOSE TO DROP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94175 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization