BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2943402 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-90617
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    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

    IT WAS REPORTED THAT THE NURSE CALLED AND REQUESTED ASSISTANCE ON HOW TO TURN OFF THE INSULIN PUMP. DURING THE CALL, IT WAS FOUND THAT THE CUSTOMER WAS HOSPITALIZED, BUT THE NURSE WAS NOT WILLING TO GIVE US MORE INFORMATION AT THE TIME. ATTEMPTED TO CALL THE CUSTOMER TO GET MORE INFORMATION, AND HE STATED THAT HE WAS HOSPITALIZED. THE CUSTOMER DOES NOT REMEMBER IF HE WAS ADMITTED FOR LOW OR HIGH BLOOD GLUCOSE, AND HE DOES NOT REMEMBER ANY DETAILS ON THE EVENT EITHER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40588 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization