BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4201279 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-42849
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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

    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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP MONITORED FOR SEVERAL DAYS AND NO BLANK DISPLAY NOTED. INSULIN PUMP RECEIVED WITH NORMAL OPERATING CURRENTS. NO DAMAGE FOUND ON THE CONNECTOR LCD ISOLATION TAPE, HOWEVER FOUND MOISTURE DAMAGE ON THE ELECTRONICS DURING VISUAL INSPECTION. NO MOISTURE DAMAGE FOUND ON THE MOTOR, BATTERY TUBE AND VIBRATOR ASSEMBLY. ALL BUTTONS FUNCTIONING PROPERLY DURING TESTING HOWEVER, FOUND MOISTURE DAMAGE TO THE KEYPAD TRACES DURING VISUAL INSPECTION. NO UNEXPECTED SCROLLING NOTED. INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, CASE CRACKED AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHES ON LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW, AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP BUTTONS WERE UNRESPONSIVE, INSULIN PUMP WAS EXPOSED TO MOISTURE, AND HAD BLANK DISPLAY. CUSTOMER STATED THAT BUTTONS WERE NOT WORKING, THERE WAS MOISTURE ON THE INSULIN PUMP AND SCREEN WENT BLANK. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 170 MG/DL. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED TO DISCONTINUE USING THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682851 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR