BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4221590 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46564
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE DEVICE WAS RECEIVED WITH NORMAL OPERATING CURRENTS AND NO BATTERY OUT LIMIT ALARM OBSERVED DURING TESTING. CRACKS TO THE RESERVOIR TUBE LIP, DISPLAY WINDOW, SCRATCHED LCD AND SCRATCHED RESERVOIR TUBE WINDOW NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUTTONS ON THE INSULIN PUMP WERE UNRESPONSIVE. CUSTOMER REPLACED THE BATTERIES AND RECEIVED A BATTERY OUT LIMIT WHICH THEY WERE UNABLE TO CLEAR. CUSTOMER STATED THAT THE SCREEN OF THE INSULIN PUMP REMAINED BLANK. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 7.3 MMOL/L. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702780 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1