BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3883390 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-85689
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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

    IT WAS REPORTED THAT THE INSULIN PUMP IS NOT DELIVERING INSULIN. CUSTOMER STATED THAT THE BLOOD GLUCOSE READING WERE FLUCTUATING. CUSTOMER EXPERIENCING HIGH BLOOD GLUCOSE OF 371 MG/DL. SIX DAYS AGO THE BLOOD GLUCOSE READING WAS 394 MG/DL. CUSTOMER FEELS SICK WHEN SHE HAS HIGH BLOOD GLUCOSE. WHEN THE INFUSION SITE IS CHANGED, THE BLOOD GLUCOSE GOES DOWN BY TEN. CUSTOMER ASKED IF THE INSULIN PUMP WILL ALARM IF SHE IS NOT RECEIVING INSULIN. CUSTOMER DOES NOT HAVE BENT CANNULAS. THE CURRENT BLOOD GLUCOSE READING IS 107 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360733 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR