BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3791182 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-84354
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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

    CUSTOMER HAD APPOINTMENT WITH PHYSICIAN, THE BASAL AND BOLUS WIZARD RATES WERE CHANGED. THE CURRENT BLOOD GLUCOSE READING IS 116 MG/DL. CUSTOMER REPORTED A LOW BLOOD GLUCOSE EVENT. CUSTOMER WAS FOUND UNCONSCIOUS BY SON, THE PARAMEDICS WERE CALLED TO RESIDENCE. CUSTOMER WAS TREATED AT THE SCENE, SHE DID NOT GO TO HOSPITAL. THE PARAMEDICS TREATED WITH IV. PATIENT HAS BEEN EXPERIENCING LOW BLOOD GLUCOSE EVENTS SEVERAL TIMES OVER THE PAST YEAR. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269304 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention