BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4182758 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39944
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING WAS 557 MG/DL, WHICH WAS TREATED FOR WITH THE INSULIN PUMP. UPON TROUBLESHOOTING, THE CUSTOMER'S WIFE STATED THAT INSULIN DID EXIT THE TUBING DURING THE MANUAL PRIME, NO LEAK WAS FOUND, AND THE INSULIN PUMP PASSED THE HIGH PRESSURE TEST. ADVISED THAT THE INSULIN PUMP WAS WORKING AS DESIGNED. ADVISED THE CUSTOMER TO CHANGE THE ENTIRE INFUSION SET, RESERVOIR AND INSULIN. ALSO ADVISED THE CUSTOMER TO ROTATE TO A DIFFERENT INSERTION SITE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661817 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR