BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4110553 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27391
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED BELT CLIP SLOT, AND CRACKED BATTERY TUBE THREADS.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 COMPLAINED ABOUT THE DESIGN OF THE INSULIN PUMP WHICH ALLOWS THE DELIVERY AMOUNT TO SCROLL PAST 0.0 UNITS TO THE MAXIMUM SETTING. CUSTOMER STATED THAT THE BASAL RATE JUMPS FROM 0.0 UNITS TO 10.0 UNITS AND THE TEMPORARY BASAL JUMPS TO 200 UNITS. CUSTOMER REQUESTED TO HAVE THE INSULIN PUMP EXCHANGED FOR ONE WITH THE UPDATED SCROLL WRAP SOFTWARE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591390 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS A3723LNASJ

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR