BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2031112 · Received March 16, 2011

    Report

    Report Number
    3004209178-2011-80680
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS OF 498 MG/DL. THE CUSTOMER'S MOTHER STATED THAT PRIOR TO THE EVENT, THE CUSTOMER WAS AT SCHOOL AND A TEACHER NOTICED THAT THE CUSTOMER WAS PALE AND HAD RED SPLOTCHES ON HER FACE. THE CUSTOMER'S MOTHER FURTHER STATED THAT THE SCHOOL NURSE CHANGED THE CUSTOMER'S SET BUT THE CUSTOMER'S BLOOD GLUCOSE CONTINUED TO SPIKE, LEADING TO THE CUSTOMER FEELING LETHARGIC. THE CUSTOMER'S MOTHER ALSO STATED THAT THE CUSTOMER HAD JUST CHANGED HER QUICKSET INFUSION SET, LOT #9201863. PROGRAMMING WAS CORRECT AND TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP PASSED THE FIXED PRIME AND THE HIGH PRESSURE TESTS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization UNOMEDICAL QUICK-SET INFUSION SET, LOT # 9201863