BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4132281 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31034
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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 THAT THE INSULIN PUMP ALARMED NO DELIVERY. CUSTOMER STATED THAT HE HAS RECENTLY RECEIVED A REPLACEMENT INSULIN PUMP. BLOOD GLUCOSE VALUE IS 245 MG/DL. CUSTOMER WAS ADVISED TO DISCONNECT AT THE QUICK RELEASE AND PERFORMED A 5.0 UNIT FIXED PRIME; INSULIN DID EXIT THE TUBING. CUSTOMER REMOVED THE INFUSION SET AND THE CANNULA WAS NOT BENT. CUSTOMER DID NOT WISH TO RUN AN ADDITIONAL FIXED PRIME TO DETERMINE IF CONNECTION MAY BE OCCLUDED. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. HE THOUGHT HE MIGHT NOT HAVE GIVEN HIMSELF ENOUGH INSULIN BOLUS. CUSTOMER WAS CONCERNED ABOUT GETTING ANOTHER NO DELIVERY ALARM. CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE INFUSION SET AND RESERVOIR. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612164 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS A3723LNASJ

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR