BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4193040 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41813
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 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

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE ON THE ACT BUTTON DUE TO CORRODED KEYPAD TRACES. NO UNEXPECTED BUTTON ERROR ALARMS NOTED. THE INSULIN PUMP HAS CRACKED LCD WINDOW, CRACKED CASE AT LCD WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, SCRATCHES ON RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS 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. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BUTTON ERROR ALARM AND THAT NONE OF HER BUTTONS WERE WORKING. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ALARM. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672100 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR