BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4132280 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31033
    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
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 EXPERIENCED HIGH BLOOD GLUCOSE. CUSTOMER CHANGED THE INFUSION SET IN THE MORNING. IT WAS STATED THAT THE INSULIN PUMP HAS DELIVERED 3 INSULIN UNITS BUT BLOOD GLUCOSE CONTINUES TO RISE. BLOOD GLUCOSE VALUE WAS 424 MG/DL. DURING TROUBLESHOOT; IT WAS STATED THE DRIVE SUPPORT CAP IS RECESSED. CUSTOMER STATED THE TUBING HAS NO AIR BUBBLES. CUSTOMER WAS ABLE TO REWIND AND PERFORM MANUAL PRIME; INSULIN DID EXIT THE TUBING. CUSTOMER DID NOT FIND AN INSULIN LEAK. TIME, DATE AND BASAL RATES ARE SET UP CORRECTLY. BOLUS WIZARD SETTINGS ARE UNKNOWN. CUSTOMER REMOVED THE INFUSION SET AND THE CANNULA IS NOT BENT OR OCCLUDED. BLOOD GLUCOSE WAS CHECKED AGAIN AND IT WAS 485 MG/DL; TREATED WITH 4 UNITS OF INSULIN WITH MANUAL INJECTION. HIGH PRESSURE TEST WAS NOT PERFORMED AS THE CUSTOMER DID NOT HAVE A TUBING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613163 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAB H8815028

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR