BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3943019 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87632
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD A BLANK DISPLAY. THE PROBLEM WAS ISOLATED TO THE LCD BOARD. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT A DISPLAY WINDOW CORNER, BROKEN BATTERY TUBE THREADS, A CRACKED RESERVOIR TUBE LIP AND A CRACKED CASE AT THE RESERVOIR TUBE WINDOW CORNER.

    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

    CUSTOMER CALLED STATING WHENEVER SHE PUSHES A BUTTON ON HER INSULIN PUMP, THE SCREEN GOES BLANK. THIS JUST STARTED HAPPENING. CUSTOMER TRIED CLEANING THE BATTERY. SHE STATES THAT THE TIME IS ADVANCING. THERE ARE BEEPS WHEN SHE PUSHES A BUTTON, BUT NOTHING CHANGES ON SCREEN. CUSTOMER'S BLOOD GLUCOSE LEVEL IS 130 MG/DL. SHE IS USING AN ENERGIZER ALKALINE BATTERY. SHE USED A POLAROID BATTERY TO TEST, BUT USUALLY USES ENERGIZER BATTERIES. THE DEVICE WAS NOT BUMPED OR DROPPED. THERE IS A CRACK ON THE BATTERY COMPARTMENT. THE DAMAGE IS DUE TO NORMAL WEAR AND TEAR. CUSTOMER WAS ADVISED THAT THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419314 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR