BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2170655 · Received July 11, 2011

    Report

    Report Number
    2032227-2011-01683
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED WITH A HIGH BLOOD GLUCOSE READING OF 389 MG/DL. THE CUSTOMER WAS EXPERIENCING MIGRAINE HEADACHES, NAUSEA, CLAMMINESS, CHEST PAIN AND A FEVER OF 102. THE CUSTOMER ALSO HAD AN EAR INFECTION. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE CUSTOMER STATED THAT THE INSULIN PUMP HAS GIVEN TWO ALARMS IN THE PAST 24 HOURS. THE CUSTOMER WAS TOO TIRED TO CONTINUE TROUBLESHOOTING. ADVISED THE CUSTOMER TO CALL BACK AT HER CONVENIENCE. 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 MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization