BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3990296 · Received August 7, 2014

    Report

    Report Number
    3004209178-2014-91110
    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
    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. 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 WAS RECEIVED WITH NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS OCCURRED DURING TESTING. THE DEVICE ALSO WAS RECEIVED WITH CRACKED CASE ON THE LCD WINDOW CORNERS, MINOR SCRATCHES ON LCD WINDOW, SCRATCHES ON THE RESERVOIR TUBE WINDOW, AND CRACKED BELT CLIP SLOT.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 THE INSULIN PUMP WAS DISPLAYING A BUTTON ERROR. AFTER TROUBLE SHOOTING, THE CUSTOMER WAS STILL UNABLE TO CLEAR THE ALARM. NO BLOOD GLUCOSE LEVEL WAS REPORTED AND THE INSULIN PUMP IS BEING REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463335 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWS

    Patients

    Seq Age Sex Outcome Treatment
    1