BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4061174 · Received September 4, 2014

    Report

    Report Number
    2032227-2014-16770
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    April 30, 2014
    Report Date
    August 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SOMETIMES WHEN HE USES HIS INSULIN PUMP AT NIGHT IT WILL ESTIMATE SIX UNITS OF INSULIN, BUT IT WILL ONLY DELIVER THREE UNITS AND STOP. SOMETIMES IT DOES NOT BEEP THE WAY IT NORMALLY DOES AFTER A DELIVERY. THIS HAPPENS ONCE IN A WHILE. CUSTOMER DECLINED TROUBLESHOOTING BECAUSE HE IS GETTING AN UPGRADE. CUSTOMER'S BLOOD GLUCOSE WAS 98 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541185 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR