BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4233485 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48840
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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

    CUSTOMER REPORTED RECEIVING A NO DELIVERY ALARM ON THE INSULIN PUMP AND STATED THAT THEY HAD BLOOD GLUCOSE READINGS OF 545 MG/DL. CUSTOMER TREATED WITH INSULIN AND THEIR BLOOD GLUCOSE READINGS WERE 252 MG/DL. CUSTOMER STATED THAT THEY DID NOT TAKE ANYMORE INSULIN. A CALL BACK WAS MADE TO ENSURE THAT THE CUSTOMER WAS OKAY AND IT WAS NOTED THAT THEIR BLOOD GLUCOSE READINGS WERE 130 MG/DL AND WAS TREATED WITH JUICE AND COOKIES. CUSTOMER'S BLOOD GLUCOSE READINGS A FEW MINUTES LATER INCREASED TO 138 MG/DL. CUSTOMER WOKE UP THE NEXT MORNING WITH BLOOD GLUCOSE READINGS OF 83 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713747 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR