BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4243121 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50300
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 13, 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
    MI
    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 HER INSULIN PUMP KEEPS ALARMING NO DELIVERY DURING THE PRIMING PROCESS. CUSTOMER'S BLOOD GLUCOSE IS 111 MG/DL. THE CONNECTION WAS VERIFIED. CUSTOMER WAS ABLE TO MANUALLY PUSH INSULIN THROUGH WITH A PLUNGER. CUSTOMER RAN A FIVE UNIT MANUAL PRIME AND THE DEVICE DID NOT ALARM NO DELIVERY. CUSTOMER WAS ADVISED THE DEVICE IS WORKING AS DESIGNED. SHE WAS ADVISED TO MONITOR THE DEVICE AND CALL BACK IF NEEDED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726745 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR