BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2925762 · Received January 22, 2013

    Report

    Report Number
    2032227-2013-00284
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 6, 2013
    Report Date
    January 6, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD UNRESPONSIVE BUTTON AND RECEIVED BUTTON ERROR ALARMS DUE TO FLATTENED DOME ON DOWN ARROW BUTTON. THE INSULIN PUMP WAS TESTED WITH A TEST KEYPAD AND NO FROZEN DISPLAY NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. THE BLOOD GLUCOSE READING WAS 112MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT THE DEVICE HAD A FROZEN DISPLAY. TROUBLESHOOTING WAS PERFORMED. INSTRUCTED THE CUSTOMER TO REMOVE THE BATTERY FOR FIVE MINUTES AND TO INSERT A NEW BATTERY, BUT THE FROZEN DISPLAY CONTINUED WITH NO ADVANCEMENT OF THE TIME. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30797 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR