BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4132441 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31099
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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 THAT THE CUSTOMER HAD BEEN EXPERIENCING LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED, THAT PRIOR TO GOING TO BED, THEIR BLOOD GLUCOSE WAS 186 MG/DL, BUT THEY WOKE UP ALMOST IN A COMA. THEY HAD TWO LIQUID GLUCOSE AND SOME CAKE ICING, AFTER WHICH THEIR BLOOD GLUCOSE INCREASED TO 282. AT THE TIME OF THE PHONE CALL THE CUSTOMER'S BLOOD GLUCOSE WAS 200 MG/DL. UPON INSPECTION IT WAS DISCOVERED THAT THE DRIVE SUPPORT CAP OF THE INSULIN PUMP WAS LOOSE. THE RESERVOIR SHOWED THE SAME AMOUNT OF INSULIN AS IT WAS DISPLAYED ON THE STATUS SCREEN OF THE DEVICE. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. THE WEEK PRIOR TO THE PHONE CALL, THE CUSTOMER'S BASAL RATES WERE CHANGED FROM 12 TO 14. THE CUSTOMER DECLINED TROUBLESHOOTING FOR THE LOW BLOOD GLUCOSE. THEY WERE ADVISED TO MONITOR THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613073 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR