BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4090306 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23203
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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

    CUSTOMER REPORTED UNEXPLAINED HIGH BLOOD GLUCOSE. SHE STATED LAST NIGHT HER BLOOD GLUCOSE WAS 480 MG/DL, AND IT ROSE TO 583 MG/DL. TODAY, HER BLOOD GLUCOSE WAS 305 MG/DL. SHE HAS BEEN TREATING WITH THE DEVICE AND SHOTS. CUSTOMER CALLED HER DOCTOR, WHO TOLD HER TO CHANGE HER INFUSION SET AND CALL THE HELP LINE. CUSTOMER STATED HER HIGHS STARTED WHEN SHE CHANGED INFUSION SETS FROM SOF SETS TO QUICK SETS. CUSTOMER EXPERIENCED GROUCHINESS, THIRST, HEAVY BREATHING, AND FREQUENT URINATION. IN TROUBLESHOOTING, 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. THE DEVICE PASSED THE HIGH PRESSURE TEST. THE CANNULA WAS OCCLUDED. CUSTOMER WAS ADVISED THAT HIGH BLOOD GLUCOSE LEVELS ARE OFTEN CAUSED BY SITE OR SET ISSUES. CUSTOMER WAS ADVISED TO DO A COMPLETE SET CHANGE AND MONITOR HIS BLOOD GLUCOSE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568913 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention