BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3100670 · Received May 8, 2013

    Report

    Report Number
    3004209178-2013-93086
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    December 9, 2012
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LOOSE/PROTRUDING SUPPORT DISK, CRACKED DISPLAY WINDOW, CRACKED RESERVOIR WINDOW, CRACKED AND BROKEN RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS NOTED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP STARTED MALFUNCTIONING IN DECEMBER 2012 AND SHE DISCONTINUED USE. CUSTOMER RECEIVED THE FIELD NOTIFICATION LETTER. THE INSULIN PUMP FALLING APART AND HAS PHYSICAL DAMAGE. DRIVE SUPPORT DISK IS PROTRUDING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200770 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR