BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS

    MDR report key: 1973967 · Received January 18, 2011

    Report

    Report Number
    3004209178-2011-80172
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 7, 2010
    Report Date
    January 7, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 FOR HIGH BLOOD GLUCOSE OF 1,100 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED NO DELIVERY AND THE CANNULA WAS BENT. THE CUSTOMER CHANGED THE INFUSION SET AND RESERVOIR AND HIS GLUCOSE LEVEL STILL WERE HIGH. THE CUSTOMER STATED THAT HE SUFFERED TWO SILENT HEART ATTACKS. THE TIME AND DATE ON THE INSULIN PUMP WERE CORRECT. THE CUSTOMER STATED THAT HE CHANGES THE INFUSION SET EVERY THREE DAYS. THE PROGRAMMING, BASAL, BOLUS, AND DAILY TOTALS WERE ACCURATE. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. PERFORMED A HIGH PRESSURE TEST AND THE DEVICE PASSED THE TEST. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization