BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2171113 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-82126
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 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
    GA, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING UNEXPLAINED HIGH BLOOD GLUCOSE AND HAD SOUGHT MEDICAL ATTENTION FROM HER DOCTOR. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 393MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS ALARMING. ADVISED THE CUSTOMER OF A POSSIBLE BLOCKAGE. THE CUSTOMER STATED THAT SENSOR WAS ALSO ALARMING AND HER GLUCOSE LEVEL WAS GETTING HIGHER. TROUBLESHOOTING WAS PERFORMED. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND THE TESTS PASSED. REVIEWED THE PROGRAMMING AND FOUND THAT THE DAILY TOTALS, BOLUS HISTORY, AND BASALS WERE NOT ACCURATE. NO FURTHER INFORMATION 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-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention