BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3990304 · Received August 7, 2014

    Report

    Report Number
    3004209178-2014-91109
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. 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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE ON THE KEYPAD TRACES. THE DEVICE WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW AND CRACKED BATTERY TUBE THREADS.THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE KEYPAD OF THE INSULIN PUMP WAS NOT RESPONSIVE. NO BLOOD GLUCOSE LEVEL REPORTED. PRODUCT IS BEING REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464346 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWP

    Patients

    Seq Age Sex Outcome Treatment
    1