BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974006 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-89006
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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

    CUSTOMER REPORTED A BLOOD GLUCOSE READING OVER 600 MG/DL. AT THE TIME OF THE TROUBLESHOOTING, THE BLOOD GLUCOSE HAD BEEN BROUGHT BACK DOWN TO 93 MG/DL. CUSTOMER STATED THAT SHE DID NOT NOTICE IF THE CANNULA WAS BENT OR KINKED. CUSTOMER EXPRESSED SYMPTOMS OF FATIGUE AND EXCESSIVE THIRST. SHE STATED THAT THE DRIVE SUPPORT CAP APPEARED TO BE NORMAL AND RECESSED. CUSTOMER FOUND NO AIR BUBBLES IN THE TUBING, AND NO LEAKS. SHE WAS ADVISED TO RUN A MANUAL PRIME AND STATED THAT INSULIN DID EXIT FROM THE TUBING. SHE STATED THAT THE SITE WAS NOT SORE OR IRRITATED. CUSTOMER ALSO REPORTED AN ISSUE WITH THE RESERVOIRS AND STATED THAT THEY DID NOT HOLD IN INSULIN AND THAT THE INSULIN WAS BEING SUCKED BACK UP INTO THE VIAL. SHE STATED THAT SHE HAD ALSO RECEIVED A NO DELIVERY ALARM. THE INSULIN PUMP PASSED THE HIGH PRESSURE TEST. CUSTOMER WAS ADVISED TO CHANGE THE INFUSION SET AND RESERVOIR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450636 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR