BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4061953 · Received September 4, 2014

    Report

    Report Number
    2032227-2014-17099
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PATIENT

    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

    THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM WAS NOTED. THE INSULIN PUMP HAD A CONSTANT FAILED BATTERY TEST ALARM DUE TO A FAULTY BATTERY TUBE. THE BATTERY TUBE WAS DISCONNECTED AND RECONNECTED TO THE INTERFACE BOARD AND NO FAILED BATTERY TEST ALARM WAS NOTED AFTERWARDS. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP WAS ALARMING BUTTON ERROR. CUSTOMER STATED THEY CHANGED THE BATTERY BUT THAT IT DID NOT RESOLVE THE ISSUE. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED IF THE DEVICE SHOWED PHYSICAL DAMAGE AND CUSTOMER STATED IT DOES NOT. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 350 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540287 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR