BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3885168 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-85959
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 31, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 HOSPITAL NURSE REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS. SHE WAS TREATED WITH INSULIN MEALS, LANTIS AT NIGHT, AND NOVOLOG SLIDING SCALE. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 900 MG/DL. PRIOR TO THE INCIDENT, THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS AND FAINTED. IT WAS ALSO STATED THAT THE INSULIN PUMP PRIMED BUT WAS NOT GIVING INSULIN. THE NURSE WAS TRYING TO FIGURE OUT HOW TO WORK THE PUMP. THE CURRENT BLOOD GLUCOSE READING IS 156 MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360742 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization