BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3841749 · Received May 30, 2014

    Report

    Report Number
    2032227-2014-02632
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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 WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. THE CUSTOMER WAS TREATED WITH THE INSULIN PUMP. THE BLOOD GLUCOSE LEVEL AT THE TIME OF THE EVENT WAS 30 MG/DL. PRIOR TO THE EVENT, THE CUSTOMER STATED HE HAD NOT EATEN FOR AWHILE AND HE FELT LOW. HE WAS DRIVING AND HIS CAR STARTED TO ZIGZAG. THIS LED TO HIM BEING PULLED OVER BY THE POLICE. THE POLICE CALLED THE PARAMEDICS. THE CURRENT BLOOD GLUCOSE READING WAS 258 MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318856 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization