BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2234131 · Received August 30, 2011

    Report

    Report Number
    3004209178-2011-82768
    Event Type
    Injury
    Date Received
    August 30, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 17, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    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 IN THE ER DUE TO HIGH BLOOD GLUCOSE OF 828 MG/DL. IT WAS STATED THAT THE CUSTOMER'S GLUCOSE DROPPED TO 476 MG/DL BY THE TIME HE WAS ADMITTED. IT WAS STATED THAT THE EVENTS LEADING HIS HOSPITALIZATION WAS NAUSEA. IT WAS STATED THAT THE CUSTOMER WAS EXPERIENCING UNEXPLAINED HIGH GLUCOSE FOR (B)(6). TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 205 MG/DL, AND HE WAS TREATED WITH AN INSULIN DRIP AND FLUID. REVIEWED THE PROGRAMMING, DATE, AND TIME AND FOUND THAT THE INSULIN PUMP WAS HOUR OFF. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND THE TESTS PASSED. NO FURTHER INFO WAS PROVIDED.

    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-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization