BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4962175 · Received August 3, 2015

    Report

    Report Number
    2032227-2015-24713
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 12, 2015
    Report Date
    July 12, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ALL OPERATING CURRENTS WERE WITHIN SPECIFICATION. NO BATTERY OUT LIMIT ALARM WAS NOTED. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, AND EXCESSIVE NO DELIVERY ALARM TESTS. HOWEVER, INTERMITTENT BUTTON RESPONSE WAS NOTED DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE, PER VARIANCE 5.

    Description of Event or Problem · 1

    THE CUSTOMER'S PARENT REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED WITH A BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE WAS 399 MG/DL. IT WAS STATED CUSTOMER'S HIGH BLOOD GLUCOSE WAS TREATED PRIOR TO THE BUTTON ERROR ALARM WITH THE INSULIN PUMP AND WAS DUE TO EATING JUNK FOOD. THE ALARM OCCURRED AFTER CUSTOMER WENT ON A LOG RIDE IN THE WATER. IT WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN. IT WAS FURTHER ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED UPON THAT THE PRODUCT WOULD BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505149 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR