BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4242775 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50257
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE HAD A WEAK BATTERY ON INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 87 MG/DL. THE CUSTOMER WAS ADVISED THAT THE USE OF OTHER BATTERY BRANDS OR OTHER TYPES OF BATTERY MAY RESULT IN REDUCE BATTERY LIFE. THE CUSTOMER WAS ADVISED TO USE AAA ALKALINE AND MONITOR THE INSULIN PUMP. THE PATIENT WAS ADVISED ALSO THAT WE WILL SHIP A REPLACEMENT OF BATTERY CAP TO RULE OUT ANY POSSIBLE ISSUES WITH THE BATTERY CAP. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725558 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR