BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3951364 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-88089
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 HAD A BLANK DISPLAY DUE TO MOISTURE DAMAGE ON ELECTRONIC ASSEMBLY. INSULIN PUMP HAD MOISTURE DAMAGE ON MOTOR. NO CONSTANT TONE NOTED. DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED. INSULIN PUMP HAD A CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP'S DRIVE SUPPORT CAP CAME OFF, WAS PROTRUDED, AND THE CUSTOMER PUSHED ON THE CAP WHILE STILL CONNECTED TO THE DEVICE. THERE WERE NO ADVERSE EFFECTS. WHEN THE SUPPORT CAP WAS PUSHED IN, ABOUT AN HOUR LATER THE INSULIN PUMP STARTED MAKING A HIGH PITCHED NOISE. THE CUSTOMER TOOK THE BATTERY OUT, TRIED PUTTING IT BACK IN, BUT THE NOISE CONTINUES. THEN, A NEW BATTERY WAS INSERTED INTO THE DEVICE AND THE DISPLAY WENT BLANK. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE CALL WAS 300 MG/DL WHICH WAS TREATED WITH MANUAL INJECTION. TROUBLESHOOTING WAS NOT PERFORMED SINCE THE DRIVE SUPPORT CAP WAS PROTRUDED AND THE DEVICE HAD TO BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428720 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR