BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4002850 · Received August 12, 2014

    Report

    Report Number
    2032227-2014-07514
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD NO BLACK SCREEN/DISPLAY ANOMALY DURING TESTING NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, BROKEN BELT CLIP SLOT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER'S FATHER THAT AFTER CHANGING THE BATTERY ON THE INSULIN PUMP, THE LCD DISPLAY SCREEN FLASHES ON AND OFF. ADVISED INSULIN PUMP WOULD BE REPLACED. NO ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479581 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR