BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4130558 · Received September 30, 2014

    Report

    Report Number
    3004209178-2014-95975
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW, CRACKED ON DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS AND BELT CLIP SLOT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BUTTON ERROR ALARM. THE CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ALARM. NO ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609081 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722WWS

    Patients

    Seq Age Sex Outcome Treatment
    1