BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3984301 · Received August 6, 2014

    Report

    Report Number
    2032227-2014-06409
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    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

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A MALFUNCTION. HER BLOOD GLUCOSE READING WAS 524 MG/DL AT THE TIME OF THE EVENT. SHE TREATED THE BLOOD GLUCOSE WITH ORANGE JUICE. IN TROUBLESHOOTING, THE PATIENT WAS ADVISED TO CONTACT A PHYSICIAN ABOUT HER HIGH BLOOD GLUCOSE. THE INSULIN PUMP PASSED DRIVE SUPPORT CAP, REWIND, AND MANUAL PRIME TESTS. THE CUSTOMER FURTHER STATED THAT THERE ARE FREQUENT LOW BATTERY ALERTS. THE PROPER METHODOLOGY AND INSTALLATION PROCEDURES FOR BATTERIES WERE EXPLAINED TO THE PATIENT. THE CUSTOMER WAS ADVISED TO REVERT TO A BACK UP PLAN IF NECESSARY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461745 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR