BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4860794 · Received June 22, 2015

    Report

    Report Number
    2032227-2015-18995
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    May 9, 2015
    Report Date
    May 9, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CLEARED DEVICE SETTINGS AND RESET ALARMS WERE NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER'S PARENT CALLED AND REPORTED THE INSULIN PUMP INDICATED THE SYSTEM WAS RESET, AND ALL SETTINGS WERE COMPLETELY LOST. CUSTOMER'S BLOOD GLUCOSE WAS 202 MG/DL. THE BATTERY HAD BEEN CHANGED OUT, HOWEVER CUSTOMER STATED THEY DID NOT USE THE CLEAR SETTINGS FEATURE IN THE MENU. A RESET ALARM WAS IN THE HISTORY. IT WAS ADVISED THAT THE CUSTOMER DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN. CUSTOMER WAS FURTHER ADVISED THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403653 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR