BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3841658 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-85272
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PROBLEMS WITH THE INSULIN PUMP. THE CUSTOMER STATES THAT THE MOTOR ERROR ALARM CAUSED HER TO HAVE LOW BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE IS 98 MG/DL. CUSTOMER'S SON CALLED THE PARAMEDICS. CUSTOMER WAS ALSO INVOLVED IN AN ACCIDENT DUE TO LOW BLOOD GLUCOSE. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318234 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization