BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4190459 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41128
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD NO BUTTON RESPONSE, DUE TO CORRODED KEYPAD TRACES. NO UNEXPECTED NUMBERS RAMPING NOTED. NO BUTTON ERROR ALARM OR FAILED BATTERY TEST ALARM NOTED. INSULIN PUMP HAD MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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 REPORTED THE INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER TOOK OUT THE BATTERY FOR AND IT ALARMED FAILED BATTERY TEST. CUSTOMER'S BLOOD GLUCOSE WAS 127 MG/DL. ALARM AND POSSIBLE CAUSES WERE EXPLAINED. CUSTOMER REPORTED THE BUTTONS ON THE DEVICE MIGHT HAVE BEEN PUSHED, WHEN ASKED IF HE RECALLED ANY SIGNIFICANT EVENTS THAT MAY CAUSED THE DEVICE TO ALARM. CUSTOMER WAS ADVISED TO REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667847 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR