BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4190444 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41127
    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
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD MOISTURE DAMAGE WAS FOUND ON KEYPAD TRACES. NO FROZEN SCREEN NOTED. ALL BUTTONS FUNCTIONED PROPERLY. ALL OPERATING CURRENTS ARE WITHIN THE SPECIFICATION, NO UNEXPECTED LOW BATTERY, BATTERY OUT OF LIMIT OR OFF NO POWER ALARM NOTED. INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS AND CRACKED BELT CLIP SLOT.

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE BUTTONS ON THE INSULIN PUMP WERE NOT RESPONDING. CUSTOMER WAS ATTEMPTING TO CHANGE THE SITE AND SHE COULDN'T DO ANYTHING THE BUTTON WERE FROZEN. CUSTOMER'S BLOOD GLUCOSE WAS 254 MG/DL, TREATED WITH THE PUMP. CUSTOMER DOES NOT RECALL ANY SIGNIFICANT EVENT THAT MAY HAVE CAUSED THE KEYPAD ISSUE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER STATED THE DEVICE ALARMED BATTERY OUT LIMIT WHEN SHE INSERTED THE BATTERY IMMEDIATELY AFTER TAKING IT OUT, UNABLE TO TROUBLESHOOT BECAUSE OF KEYPAD ISSUE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667782 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR