BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4213454 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43262
    Event Type
    Malfunction
    Date Received
    October 25, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 REPORTS NO INSULIN DELIVERY FROM INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 364 MG/DL, WHICH WAS TREATED WITH MANUAL INJECTION. TROUBLESHOOTING COULD NOT BE CONTINUED AS CUSTOMER DID NOT HAVE TUBING CLAMP TO COMPLETE HIGH PRESSURE TEST. CUSTOMER WAS ABLE TO RUN INSULIN THROUGH QUICK RELEASE AND RECONNECT TO INFUSION SET. CUSTOMER WILL CALL BACK ONCE HE RECEIVES TUBING CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680419 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR