BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4221576 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46550
    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
    MD
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WAS RECEIVED WITH AN INTERMITTENT BUTTON RESPONSE, DUE TO MOISTURE DAMAGE ON KEYPAD TRACES. NO KEYPAD OR BUTTON SCROLLING UP NOTED. INSULIN PUMP HAD A CRACKED CASE ON DISPLAY WINDOW CORNER, MINOR SCRATCHES ON LCD WINDOW, CRACKED BELT CLIP SLOT ON BATTERY TUBE THREADS AREA AND CRACKED RESERVOIR TUBE LIP.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE KEYPAD WAS SCROLLING DURING BOLUS. CUSTOMER STATED THAT IT STOPPED MID DELIVERY AND WOULD NOT RESUME. CUSTOMER STATED THAT THEY PREVIOUSLY FELL IN WATER. CUSTOMER'S BLOOD GLUCOSE READINGS AT THE TIME OF THE CALL WERE 205 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702733 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR