BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920046 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86495
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 BY THE CUSTOMER THAT HE BELIEVES HIS INSULIN PUMP IS NOT DELIVERING ENOUGH INSULIN AND BELIEVES IT MAY BE THE RESERVOIR. CUSTOMER STATES THAT HIS BLOOD GLUCOSE LEVEL WAS 260 MG/DL THE PREVIOUS DAY AT WORK, WHICH PROMPTED HIM TO BOLUS AND REACHED 258 MG/DL. UPON ARRIVING HOME, HIS BLOOD GLUCOSE LEVEL WAS 204 MG/DL AND TWO HOURS AFTER LUNCH HAD REACHED 193 MG/DL. ALSO, CUSTOMER STATED THAT HE HAD CHANGED OUT THE INFUSION SET AND RESERVOIR. THE FOLLOWING MORNING, THE CUSTOMER HAD A BLOOD GLUCOSE LEVEL OF 67 MG/DL AND TREATED WITH ORANGE JUICE, BRINGING IT BACK UP TO 111 MG/DL. CUSTOMER WAS ADVISED TO DISCONNECT FROM DEVICE. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED TO CHECK THE CONDITION OF THE DRIVE SUPPORT CAP AND IT WAS FOUND TO BE RECESSED INTO THE DEVICE. NEXT, CUSTOMER WAS ASKED TO CHECK THE INFUSION SET AND RESERVOIR FOR ANY SIGNS OF DAMAGE. CUSTOMER VERIFIED NO DAMAGE FOUND. CUSTOMER WAS ADVISED THE DEVICE WAS FUNCTIONING PROPERLY. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395711 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR