BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3112600 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-93479
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    February 24, 2013
    Report Date
    February 24, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH PROTRUDED/LOOSE DRIVE SUPPORT DISK. ALSO RECEIVED WITH DETACHED END CAP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAS COSMETIC DAMAGE. CUSTOMER'S BLOOD GLUCOSE READING IS 71 MG/DL. THE DRIVE SUPPORT CAP IS PROTRUDED. ADVISED CUSTOMER NOT TO MANIPULATE OR PUSH ON THE DRIVE SUPPORT CAP WHILE CONNECTED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212606 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522WWP

    Patients

    Seq Age Sex Outcome Treatment
    1