BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3972048 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05061
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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

    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

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, OPERATING CURRENTS, SELF TEST AND OFF NO POWER TEST. NO BATTERY OUT LIMIT ALARM NOTED. THE DEVICE WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO RAMPING NUMBERS ANOMALY NOTED. THE UNIT ALSO WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE DISPLAY WINDOW CORNER AND CRACKED RESERVOIR TUBE LIP. 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

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP SCREEN DISPLAYED NUMBERS RAMPING UP ON THEIR OWN. SHE TOOK OUT THE BATTERY AND REPLACED IT AFTER A MINUTE AND THE INSULIN PUMP CEASED TO FUNCTION. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 14.1 MMOL/L. SHE WAS ADVISED TO DISCONTINUE USING HER PUMP AND TO REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448467 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754LCMH

    Patients

    Seq Age Sex Outcome Treatment
    1