BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2943404 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-90625
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 16, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 400MG/DL. TROUBLESHOOTING WAS PERFORMED. THE TIME AND DATE WERE INCORRECT. ASSISTED THE CALLER WITH CORRECTING THEM. IT WAS STATED THAT THE TIME WAS ON MILITARY TIME, WHICH MAY HAVE BE THE CAUSE OF HER LOW AND HIGH BLOOD GLUCOSE LEVEL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40164 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization