BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2218526 · Received August 15, 2011

    Report

    Report Number
    2032227-2011-02059
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 3, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 HOSPITALIZED DUE TO HIGH AND LOW BLOOD GLUCOSE LEVELS RANGING FORM 49 10 1200 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND NO SIGNIFICANT ALARMS WERE FOUND IN THE ALARM HISTORY. FURTHER TROUBLESHOOTING WAS NOT POSSIBLE AS THE CUSTOMER DID NOT FEEL WELL AND THE CALLER DID NOT HAVE ADDITIONAL INFUSION SETS. 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-723RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization