BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4801349 · Received May 28, 2015

    Report

    Report Number
    3004209178-2015-59931
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    May 7, 2015
    Report Date
    May 7, 2015
    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

    CUSTOMER REPORTED VIA PHONE, THE INSULIN PUMP HAD KEPT ALARMING NO DELIVERY AND IT WAS THE FOURTH OR FIFTH TIME THE INFUSION SET FAILED. CUSTOMER HAD CALLED IN AND PERFORMED TROUBLESHOOTING BUT THE DEVICE ALARMED AGAIN. CUSTOMER DIDN'T NOTICE AND DAMAGE TO THE INFUSION SET AND ALARM OCCURRED DURING BASAL. CUSTOMER DOESN'T RECALL HIS BLOOD GLUCOSE LEVEL AT THE TIME OF THE ALARM. THERE HAVE BEEN PREVIOUS REPORTS OF TROUBLESHOOTING PERFORMED. CUSTOMER HADN'T TRIED ALL POSSIBLE SOLUTIONS. CUSTOMER WAS SENT DIFFERENT CANNULA SIZE INFUSION SETS. CUSTOMER WAS ADVISED TO MONITOR THE DEVICE, TRY NEW INFUSION SETS THAT WERE BEING SENT, AND CALL BACK IF ISSUES PERSISTED. CUSTOMER IS NOT RETURNING THE INSULIN PUMP FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346763 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR