BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4112107 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27499
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO NUMBER RAMPING ANOMALY OR SCROLL BAR ANOMALY WAS NOTED. ALL OPERATING CURRENTS WERE WITHIN SPECIFICATION AND NO BATTERY OUT LIMIT ALARMS WERE NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP, AND A CRACKED BELT CLIP SLOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CUSTOMER TRIED ENTERING INFORMATION INTO THE INSULIN PUMP, THE NUMBERS KEPT SCROLLING UP. THE NUMBERS COULD NOT BE STOPPED BECAUSE THE BUTTONS WERE UNRESPONSIVE. THE CUSTOMER REPLACED THE BATTERY. THE CUSTOMER'S BLOOD GLUCOSE WAS 216 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER REMOVED AND REINSERTED THE BATTERY, AFTER WHICH THE INSULIN PUMP ALARMED BATTERY OUT LIMIT. THE CUSTOMER STATED THAT THE BATTERY WAS NOT OUT OF THE DEVICE GREATER THAN THE ALLOWED DURATION. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591977 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR