BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4190448 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41138
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED FUNCTIONAL TESTING AND SELF TEST. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. ALL BUTTONS FUNCTIONED PROPERLY HOWEVER MOISTURE DAMAGE NOTED ON ELECTRONIC ASSEMBLY AND KEYPAD TRACES DURING VISUAL INSPECTION. THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE ON DISPLAY WINDOW CORNERS, MINOR SCRATCHES ON LIQUID CRYSTAL DISPLAY WINDOW AND CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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

    CUSTOMER REPORTED SHE THINKS THE INSULIN PUMP OVER HEATED. CUSTOMER WENT ON A LONG RUN AND HAD THE DEVICE IN HER BRA. CUSTOMER STATED WHEN SHE GOT HOME THE DEVICE HAD A BLANK DISPLAY. SHE INSERTED A NEW BATTERY AND THE DEVICE STILL HAD A BLANK DISPLAY. CUSTOMER STATED SHE LEFT THE DEVICE FOR AWHILE AND IT TURNED BACK ON. SHE ATTEMPTED TO BOLUS BUT THE UP AND ACT BUTTONS WERE NOT WORKING. THE B BUTTON DOESN'T RESPOND EITHER. CUSTOMER STATED THERE WAS CONDENSATION UNDERNEATH THE SCREEN. THE DEVICE WAS NOT DROPPED OR BUMPED. CUSTOMER'S BLOOD GLUCOSE WAS 2.4MMOL/L. CUSTOMER WAS ADVISED TO DISCONTINUE USE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667545 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CAS

    Patients

    Seq Age Sex Outcome Treatment
    1