BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAS

    MDR report key: 7587518 · Received June 11, 2018

    Report

    Report Number
    3004209178-2018-79570
    Event Type
    Injury
    Date Received
    June 11, 2018
    Date of Event
    May 10, 2018
    Report Date
    August 9, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169507258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT HAS BEEN ADDED TO THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVEL WAS 500MG/DL. CUSTOMER EXPERIENCED DIFFERENT BLOOD GLUCOSE LEVEL WAS 212, 499, 315 MG/DL. CUSTOMER STATED THAT THEY DID NOT ALLEGE PUMP WAS UNDER DELIVERING AND CANNULA WAS NOT BENT. CUSTOMER DECLINED FOR TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE .THE PRODUCT WILL NOT BE RETURN FOR THE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430213 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS B5723NASJ 00643169507258

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other