BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4945714 · Received July 28, 2015

    Report

    Report Number
    2032227-2015-23705
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Date of Event
    July 4, 2015
    Report Date
    July 4, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RECEIVED WITH AN INTERMITTENT BUTTON RESPONSE DUE TO THE CORRODED KEYPAD TRACES. THE PUMP WAS ALSO RECEIVED WITH NORMAL OPERATING CURRENTS. THERE WAS NO UNEXPECTED BATTERY OUT LIMIT AND NO UNEXPECTED BATTERY ALARM NOTED. IT WAS NOTED THAT NO MOISTURE DAMAGE WAS FOUND ON THE LCD, THE ELECTRONICS, MOTOR, BATTERY TUBE, AND THE VIBRATOR. THE PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, A MINOR SCRATCHED LCD WINDOW, A SCRATCHED RESERVOIR TUBE WINDOW, AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HIS INSULIN PUMP GOT WET. CUSTOMER STATED THAT HE WAS ON A BOAT AND HE GOT STUCK IN A HARD DOWNPOUR WITH THE PUMP IN HIS POCKET. THE CUSTOMER PLACED A BRAND NEW BATTERY IN THE PUMP, BUT RECEIVED A BATTERY OUT LIMIT ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 102 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER REPORTED THAT THERE WAS FLUID UNDER THE LCD DISPLAY. CUSTOMER STATED THAT THE PUMP ALARMED AFTER A BATTERY CHANGE AND HE COULD NOT CONTINUE TROUBLESHOOTING BECAUSE THE BUTTONS WERE UNRESPONSIVE. CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ALSO ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492028 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR