BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4213457 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-36921
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INSULIN PUMP WAS RECEIVED WITH BROKEN BATTERY TUBE THREADS, BROKEN BATTERY CAP, SEVERELY SCRATCHED LCD WINDOW AND MISSING END CAP.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP WAS DAMAGED. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED IF THE DEVICE SHOWED PHYSICAL DAMAGE AND CUSTOMER STATED IT DOES NOT. NEXT, CUSTOMER WAS ASKED IF THE BATTERY COMPARTMENT APPEARED DAMAGED. CUSTOMER STATED THE BATTERY CAP AND BATTERY THREADS ARE WORN. ADVISED TO DISCONTINUE USE AND REVERT TO BACK UP PLAN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 168 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647348 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR