BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4132141 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31008
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 25, 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
    MO
    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED BECAUSE SHE WAS TRYING TO SET UP A NEW RESERVOIR FOR HER INSULIN PUMP, BUT THE ACT BUTTON WOULD NOT REWIND THE DEVICE. CUSTOMER WAS RUNNING A DUAL BOLUS. SHE WAS ADVISED THAT WHEN THE DEVICE IS IN A SPECIAL MODE, THE ACT BUTTON WILL NOT ALLOW REWIND. CUSTOMER THEN SUSPENDED THE BOLUS AND TRIED PRESSING ACT TO REWIND AND IT WORKED. CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 302 MG/DL. SHE JUST ATE DINNER AND TREATED WITH THE DEVICE. IN TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE, THE DRIVE SUPPORT CAP APPEARED NORMAL. THERE WAS NO AIR IN THE TUBING. INSULIN EXITED DURING THE MANUAL PRIME. THERE WAS NO LEAK. THE SETTINGS AND HISTORY ARE CORRECT. CUSTOMER COULD NOT COMPLETE TROUBLESHOOTING BECAUSE SHE HAD TO LEAVE. SHE STATED SHE WOULD CALL BACK TO COMPLETE THE HIGH PRESSURE TEST. CUSTOMER ALSO REPORTED THAT SHE HAD A COUPLE OF LOWS RECENTLY. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610125 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR