BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4151774 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-92469
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    June 29, 2014
    Report Date
    July 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE KEYPAD TRACES. NO UNEXPECTED NUMBERS RAMPING DURING TESTING. THE INSULIN PUMP RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHES ON LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW, BROKEN BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 IS REPORTED THAT THE CUSTOMER HAS AN ISSUE WITH THE BUTTONS AND SCREEN MALFUNCTIONING ON THE INSULIN PUMP. THEIR BLOOD GLUCOSE LEVEL WAS 128MG/DL. THE CUSTOMER STATES SHE TRIED TO CLEAR IT BUT CANNOT. TROUBLESHOOTING WAS DONE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632443 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722CAP

    Patients

    Seq Age Sex Outcome Treatment
    1