BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974117 · Received August 1, 2014

    Report

    Report Number
    2032227-2014-05259
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 28, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 WENT TO THE EMERGENCY ROOM FOR HIGH BLOOD GLUCOSE OF 384 MG/DL. CUSTOMER WAS TREATED AND RELEASED. CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 235 MG/DL. CUSTOMER'S MOTHER REPORTED PRIOR TO EMERGENCY ROOM VISIT THE CUSTOMER'S BLOOD GLUCOSE KEPT FLUCTUATING, HIGH THEN LOW THEN HIGH AGAIN. TROUBLESHOOTING WAS PERFORMED. CUSTOMER'S SYMPTOMS WERE NAUSEA, VOMITING, SICK TO HER STOMACH, SLEEPINESS, FACE WAS FLUSHED, AND ATTITUDE. DRIVE SUPPORT CAP APPEARS NORMAL. NEW SET WAS CONNECTED AND MANUAL PRIME WAS PERFORMED INSULIN DID EXIT. NO LEAKS NOTED. SETTINGS WERE CORRECT ON THE DEVICE. DEVICE PASSED HIGH PRESSURE TEST. INSULIN WAS FINE. CUSTOMER'S MOTHER STATED SHE WAS INFORMED THAT CUSTOMER COULD WEAR THE INFUSION SET FOR FOUR DAYS. AS WELL AS, SHE COULD CONNECT THE SET AND THEN DISCONNECT AND DO THE PRIMING. CUSTOMER'S MOTHER WAS EXPLAINED PROPER PROCESS. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450740 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization