BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4221571 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46574
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. NO BUTTON ERROR ALARM NOTED. INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. MOISTURE DAMAGE ON LIQUID CRYSTAL DISPLAY BOARD. CRACKED CASE NEAR LIQUID CRYSTAL DISPLAY WINDOW CORNER, MINOR SCRATCHES TO LIQUID CRYSTAL DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, SCRATCHED RESEVOIR TUBE WINDOW AND STAINED END CAP STICKER.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. NO BUTTON ERROR ALARM NOTED. INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. MOISTURE DAMAGE ON LIQUID CRYSTAL DISPLAY BOARD. CRACKED CASE NEAR LIQUID CRYSTAL DISPLAY WINDOW CORNER, MINOR SCRATCHES TO LIQUID CRYSTAL DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, SCRATCHED RESEVOIR TUBE WINDOW AND STAINED END CAP STICKER.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP APPEARED TO BE DAMAGED. CUSTOMER STATED THE DEVICE HAD BEEN EXPOSED TO MOISTURE AND THE KEYPAD WAS UNRESPONSIVE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 8.4 MMOL/L AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703344 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754LCMH

    Patients

    Seq Age Sex Outcome Treatment
    1