BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4161887 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36091
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    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

    CUSTOMER REPORTED AN ABSENCE OF NO DELIVERY ALARM. SHE STATED SHE HAD NOT EATEN IN 12 HOURS AND HER BLOOD GLUCOSE WAS GOING UP BUT THERE WAS NO ALERTS FROM HER INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 265 MG/DL. SHE HAD TREATED WITH MANUAL INJECTIONS. TROUBLESHOOTING FOUND THE INSULIN PUMP DID ALARM WITH LESS THAN 5 UNITS OF INSULIN. THE CUSTOMER ALSO STATED HER CANNULA WAS BENT, BUT SHE WAS UNSURE IF IT WAS HER FAULT. THE CUSTOMER WAS ADVISED TO MONITOR HER INSULIN PUMP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640499 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR