BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4181203 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39454
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    May 25, 2014
    Report Date
    June 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT WAS SET TO PROPER TIME AND DATE AND NO UNEXPECTED A17, A21, RESET ALARM, FROZEN SCREEN, OR CHECK SETTINGS ALARMS NOTED. UNIT PASSED DISPLACEMENT TEST, SELF TEST, AND A21 ERROR TEST. A47 ALARM CONFIRM IN ALARM HISTORY SCREEN. A47 ALARMS DUE TO CORRUPTED HISTORY FILE. UNIT RECEIVED WITH MINOR SCRATCHED LCD WINDOW AND CRACKED RESERVOIR TUBE LIP. LOW BATTERY ALERT FUNCTIONED PROPERLY DURING TESTING. UNABLE TO PROGRAM FOOD OR BG VALUES DUE TO BOLUS WIZARD WAS OFF AND NO SETTINGS AVAILABLE. PROGRAM BOLUS WIZARD SETTINGS USING 723/523 USER GUIDE. UNIT FUNCTIONED PROPERLY AFTERWARDS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIS INSULIN PUMP WAS FROZEN, BUT HE COULD STILL SEE THE TIME. THE CUSTOMER ALSO REPORTED HIS BLOOD GLUCOSE WAS HIGH BECAUSE HIS INSULIN PUMP WAS NOT DELIVERING INSULIN. THE CUSTOMER ALSO STATED HE DID NOT HAVE HIS SETTINGS. THE CUSTOMER ALSO REPORTED RECEIVING SEVERAL ALARMS. HE DECLINED TO TROUBLESHOOT FOR THE ALARMS. THE CUSTOMER ALSO STATED HE WAS UNABLE TO INPUT HIS FOOD AND BLOOD GLUCOSE FOR BOLUSES ON HIS INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 320 MG/DL. HE STATED HE HAD TREATED HIS BLOOD GLUCOSE WITH A SYRINGE. TROUBLESHOOTING FOUND THE CORRECT BOLUS AMOUNT WAS RECORDED IN THE BOLUS HISTORY. THE CUSTOMER STATED THIS TEMP BASAL WAS NOT PROGRAMMED BEFORE THE ALARM OCCURRED. CUSTOMER WAS ADVISED TO REPLACE HIS INSULIN PUMP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662079 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 43 YR