BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3192819 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-95121
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    DIABETES EDUCATOR CALLED TO CONFIRM THAT INSULIN PUMP IS WORKING PROPERLY, CUSTOMER WAS ADMITTED TO HOSPITAL FOR DIABETIC KETOACIDOSIS. THE CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 143 MG/DL. THE CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 654 MG/DL. DURING TROUBLESHOOTING, MANUAL PRIME IS CORRECT, INSULIN EXITED THE TUBING. HIGH PRESSURE TEST PASSED. PROGRAMMING IS CORRECT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292211 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization