BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4141813 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33595
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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

    IT IS REPORTED THAT A CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS AT 800 MG/DL. THE CUSTOMER WAS TREATED FOR THE HIGH BLOOD GLUCOSE WITH A INSULIN DRIP. THE CUSTOMER WAS INFORMED THAT THERE COULD BE MANY REASONS FOR HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT THEIR INFUSION SET HAD EXPIRED. NEW INFUSION SETS WERE SENT TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621789 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization