BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2234068 · Received August 29, 2011

    Report

    Report Number
    3004209178-2011-82721
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    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 CUSTOMER WAS VOMITING AND HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 543MG/DL. IT WAS STATED THAT THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE FOR THE PAST DAY. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND THE TESTS PASSED. IT WAS STATED THAT THE CUSTOMER HAD PROBLEMS WITH THE TAPE STICKING. THE CUSTOMER CALLED BACK AND STATED THAT HER HUSBAND MEASURES HIS GLUCOSE AND IT WAS 230MG/DL. ADVISED THAT THE CUSTOMER SHOULD CONSIDER CHANGING THE INFUSION SET AND SITE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization