BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3231380 · Received July 17, 2013

    Report

    Report Number
    2032227-2013-02984
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A HOSPITALIZATION FOR LOW BLOOD GLUCOSE. THE CURRENT BLOOD GLUCOSE READING IS 83 MG/DL. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 43 MG/DL. PARAMEDICS WERE CALL TO STABILIZE BLOOD GLUCOSE. CUSTOMER WAS INCOHERENT. CUSTOMER ALSO FELL AND COULD NOT WAKE UP. CUSTOMER WAS TREATED AT HOME. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330882 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization