BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS

    MDR report key: 1962744 · Received January 11, 2011

    Report

    Report Number
    3004209178-2011-80121
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    January 2, 2011
    Report Date
    January 3, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    IT WAS REPORTED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE THE NIGHT BEFORE. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE INFUSION SET WAS CHANGE IN THE AFTERNOON, AND THE CUSTOMER'S GLUCOSE LEVEL WAS HIGH FOR SEVERAL HOURS. THEN, THE CUSTOMER HAD LOW BLOOD GLUCOSE BEFORE BEDTIME AND THE CUSTOMER TREATED. DURING THE NIGHT, THE CUSTOMER'S BLOOD GLUCOSE DROPPED TO 20MG/DL, AND PARAMEDICS WERE CALLED. IT WAS STATED THAT THE CUSTOMER IS SICK AND IT MAY BE CONTRIBUTING TO CHANGE HIS BLOOD GLUCOSE. THE TIME ON THE INSULIN PUMP WAS AN HOUR AHEAD. THE PROGRAMMING ON THE DEVICE WAS ACCURATE. NO FURTHER INFO 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 66 YR Hospitalization