BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3981663 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06036
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER HAD A NEW INSULIN PUMP AND HAVING HIGH BLOOD GLUCOSE. CUSTOMER FILLED INSULIN PUMP AND HER BLOOD GLUCOSE WAS 400MG/DL, SHE TOOK INSULIN FEW HOURS LATER CONTINUED BEING HIGH. CUSTOMER STATED AT BEDTIME HER BLOOD GLUCOSE WAS 434MG/DL, SHE WAS NOT FEELING WELL AT NIGHT GOT UP AND WAS 467MG/DL. CUSTOMER TREATED HERSELF WITH 24 UNITS OF INSULIN. IN THE MORNING CUSTOMER'S BLOOD GLUCOSE WAS 461MG/DL. CUSTOMER BELIEVES THERE IS AN ISSUE WITH INSULIN PUMP. CUSTOMER STATED SHE HAD A BACK UP PLAN. DURING TROUBLESHOOTING INSULIN PUMP HAD NO AIR BUBBLES, INSULIN DID EXIT TUBING, BOLUS SETTINGS ARE CORRECT. INSULIN PUMP WORKING AS DESIGNED. ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR AND INSULIN, AFTER SET CHANGE THE BLOOD GLUCOSE WAS 485MG/DL, SHE DELIVERED 30.9 UNITS BOLUS. THE BLOOD GLUCOSE READING WAS 461MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456289 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR