BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4153389 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-25740
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH BLANK DISPLAY DUE TO BATTERY TUBE CONNECTOR NOT PLUGGED IN PROPERLY. LOW BATTERY ALARM, OFF NO POWER ALARM WAS NOT VERIFIED AND FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO BLANK DISPLAY. THE DEVICE HAD MINOR SCRATCHED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD A BLANK DISPLAY AFTER ALARMING A LOW BATTERY WARNING. THE BLOOD GLUCOSE READING WAS 180 MG/DL. THE CUSTOMER STATED THAT SHE CHANGED THE BATTERY, BUT THE SCREEN KEPT TURNING ON AND OFF. SHE NOTED THAT THE SCREEN HAD STOPPED DOING ANYTHING ALTOGETHER. THE DISPLAY DID NOT RETURN UPON TROUBLESHOOTING. THE CUSTOMER ALSO REPORTED THAT SHE HAD ISSUES WITH AIR BUBBLES AND HAD TO GO THROUGH 6 TO 7 INFUSION SETS BECAUSE OF IT. SHE STATED THAT SHE HAD NOT BEEN TOLD TO MAKE SURE THAT SHE PULLED THE PLUNGER STRAIGHT DOWN. ADVISED REPLACEMENT OF THE INSULIN PUMP. DURING LATER CONTACT WITH THE CUSTOMER, IT WAS FOUND THAT THE INSULIN PUMP HAD NOT YET BEEN RETURNED FOR ANALYSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630734 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR