BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4112239 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-94829
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    November 23, 2013
    Report Date
    November 23, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WAS RECEIVED WITH SCRATCHED LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACK ON RESERVOIR TUBE LIP, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS, MISSING END CAP STICKER AND PEELING KEYPAD OVERLAY. NO CRACKED DISPLAY NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAS A CRACK IN THE CASE. CUSTOMER STATED THAT THE CRACK IS SEEN ON THE DISPLAY. THE DRIVE SUPPORT CAP HAS NO DAMAGE. THE INSULIN PUMP HAS NOT BEEN DROPPED OR BUMPED. NOTING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591907 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522WWS

    Patients

    Seq Age Sex Outcome Treatment
    1