BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3111146 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-93404
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH PROTRUDED DRIVE SUPPORT DISK AND A SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    CUSTOMER CALLED REGARDING THE FIELD NOTIFICATION LETTER. CUSTOMER'S BLOOD GLUCOSE READING IS 319 MG/DL. CUSTOMER HAS TREATED BLOOD GLUCOSE WITH THE INSULIN PUMP. CUSTOMER STATES THAT THE DRIVE SUPPORT CAP IS PROTRUDED. CUSTOMER HAS PRESSED THE CAP WHILE CONNECTED. ADVISED CUSTOMER THAT INSULIN PUMP MUST BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213000 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR