BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4182594 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39696
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO FLATTENED ALL THE BUTTONS DOME SWITCH. NO STUCK BUTTONS NOTED. UNIT HAD NORMAL OPERATING CURRENTS AND NO UNEXPECTED OFF NO POWER OR LOW BATTERY ALARM NOTED. UNIT PASSED FUNCTIONAL TESTINGS INCLUDING DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33 AND NO DELIVERY TESTS. UNIT HAD MINOR SCRATCHED LCD WINDOW, CRACKED DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP AND STAINED END CAP STICKER. NO BURNT MARKS NOTED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HOSPITALIZATION AND THAT THE INSULIN BUTTONS WERE UNRESPONSIVE. CUSTOMER STATED THAT THE BUTTONS WERE STICKING. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 123 MG/DL. CUSTOMER MENTIONED THAT THE INSULIN PUMP LOOKS BURNT. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. CUSTOMER STATED ALSO THAT THERE WAS EMERGENCY ROOM VISIT DUE TO HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE WAS 400 MG/DL. THE CAUSE OF THE EMERGENCY VISIT WAS UNCONTROLLED DIABETES. CUSTOMER STAYED FOR A FEW DAYS AND WAS RELEASED. CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF EMERGENCY ROOM VISIT. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660256 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization