BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3951355 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-88094
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    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

    CUSTOMER REPORTED THAT THE INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME. CUSTOMER STATED THAT HE HAS AN ISSUE WITH THE INSULIN PUMP TIMING OUT AND STATES THAT THE INSULIN PUMP IS NOT WORKING. CUSTOMER REPORTED THAT HE FILLED UP THE INSULIN PUMP AND IT CONTINUES TO TELL HIM TO FILL UP MORE. CUSTOMER ALSO MENTIONED NOTICING AIR BUBBLES IN THE TUBING. CUSTOMER ALSO STATED THAT THE INSULIN PUMP COULD NOT PUSH THE RESERVOIR FORWARD TO RELEASE ANY INSULIN DROPS. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 118 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428710 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR