BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6138523 · Received December 1, 2016

    Report

    Report Number
    2032227-2016-46857
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    October 31, 2016
    Report Date
    November 4, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE, PER VARIANCE 5.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THE DEVICE ALARMED NO DELIVERY ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 408 MG/DL. CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH BOLUS. CUSTOMER HAD CHANGED THE RESERVOIR AND SET FOUR TIMES FOR THE NO DELIVERY ALARM. CUSTOMER HAD TO CONNECT AND DISCONNECT THE SET COUPLE TIMES FOR THE INSULIN TO BE DELIVERED. AFTER TROUBLESHOOTING, CUSTOMER WAS ADVISED THE SET AND RESERVOIR WILL BE REPLACED. CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789300 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other