BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3942337 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87538
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    THE BOLUS WIZARD FUNCTIONS PROPERLY PER BOLUS WIZARD SAMPLE IN THE USER GUIDE. ENTERED THE TEST BLOOD GLUCOSE VALUE AND THEN THE CARBOHYDRATE VALUE THE BLOOD GLUCOSE VALUE AND CARBOHYDRATE VALUE WAS NOT LISTED TOGETHER. THE UNIT WAS ABLE TO DELIVER CORRECT THE ESTIMATE BOLUS. THE BOLUS WIZARD ENTRY CORRECTLY LISTED THE BLOOD GLUCOSE VALUE AND CARBOHYDRATE VALUE SEPARATELY IN THE BOLUS HISTORY SCREEN. NO BOLUS ANOMALY OR HISTORY ANOMALY NOTED. INSULIN PUMP PASSED SELF TEST AND DISPLACEMENT TEST. INSULIN PUMP HAD MINOR SCRATCHED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, BROKEN BELT CLIP SLOT, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE WINDOW AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS ARE NOT MATCHING UP WITH THE READINGS ON HER INSULIN PUMP. CUSTOMER STATED THAT SOMETIMES SHE ENTERS HER BLOOD GLUCOSE LEVELS AND THEY SHOW UP ON THE INSULIN PUMP AS CARBS. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 55 MG/DL AND HAS TREATED WITH FOOD AND JUICE. CUSTOMER STATED THAT SHE BLOUSED 65 CARBS INTO THE INSULIN PUMP AND THEY ARE SHOWING UP AS 55 CARBS. CUSTOMER ALSO STATED THAT HER PREVIOUS BLOOD GLUCOSE READING WENT INTO THE INSULIN PUMP CORRECTLY, HOWEVER NO CARBS WERE ENTERED AND THE INSULIN PUMP SHOWED 95 CARBS. CUSTOMER WAS ADVISED TO REVERT TO A BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419422 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 13 YR