BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123118 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29725
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT, OPERATING CURRENTS, SELF TEST AND OFF NO POWER TESTS. NO UNEXPECTED LOW BATTERY ALARMS WERE NOTED. THE INSULIN PUMP WAS MONITORED AND NO VIBRATING ANOMALY AND NO BLANK DISPLAY WERE NOTED DURING TESTING. THE INSULIN PUMP HAD INTERMITTENT MISSING SEGMENTS DURING THE BUTTON PRESS DUE TO A COLD SOLDER JOINT ON THE DISPLAY ASSEMBLY. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED CASE AT A DISPLAY WINDOW CORNER AND A CRACKED RESERVOIR TUBE LIP.

    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

    IT WAS REPORTED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER'S BLOOD GLUCOSE WAS 327 MG/DL. THE CUSTOMER STATED THAT FOR A COUPLED OF WEEKS THE TIME AND THE DATE ICONS WERE NOT SHOWING ON THE SCREEN OF THE INSULIN PUMP. THE CUSTOMER INSERTED A NEW BATTERY AND THE SCREEN SHOWED THE BATTERY STATUS, THE DEVICES STARTED VIBRATING, AND THE DISPLAY WAS BLANK; THERE WERE SOME LINES ON THE SCREEN AND THERE WAS A BLANK SPOT IN THE NUMBERS. THE CUSTOMER WAS ADVISED THAT THE DEVICE NEEDED TO BE REPLACED. THE CUSTOMER HAD REVERTED TO A BACKUP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601138 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR