BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 1993444 · Received February 8, 2011

    Report

    Report Number
    3004209178-2011-80351
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 WAS IN THE INTENSIVE CARE UNIT FROM A SURGERY AFTER BEING ADMITTED FOR HIGH BLOOD GLUCOSE. IT WAS STATED THAT THE CUSTOMER'S BLOOD GLUCOSE WERE SO HIGH THAT THEY DID NOT REGISTER. IT WAS STATED THAT THE CUSTOMER WAS DEALING WITH HIGH BLOOD GLUCOSE OF 259 MG/DL WHEN SHE WENT TO BED. THE CUSTOMER WOKE UP, TESTED AGAIN AND THE GLUCOSE LEVEL DID NOT DROP. IT WAS STATED THAT THE CUSTOMER CHANGES THE INFUSION SET EVERY THREE DAYS. IT WAS STATED THAT THE DEVICE OFTEN ALARMED NO DELIVERY, AND THE BOLUS HISTORY SHOWED A 20 UNITS BOLUS THE MORNING SHE WAS TAKEN TO THE HOSPITAL. 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-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization