BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4010922 · Received August 14, 2014

    Report

    Report Number
    3004209178-2014-93740
    Event Type
    Malfunction
    Date Received
    August 14, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 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

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. INSULIN PUMP HAD A CRACKED DISPLAY WINDOW CORNER, BROKEN BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER.

    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.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THEY KEYPAD OF THE INSULIN PUMP STOPPED WORKING WHILE SHE WAS ATTEMPTING TO BOLUS. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP RETURNED A LOW RESERVOIR ALERT THAT SHE ATTEMPTED TO CLEAR, BUT WAS UNABLE TO DUE TO THE KEYPAD NOT RESPONDING. BLOOD GLUCOSE LEVEL WAS 137 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487198 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP A4523NAPJ

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR