BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7166098 · Received January 4, 2018

    Report

    Report Number
    3004209178-2018-40941
    Event Type
    Injury
    Date Received
    January 4, 2018
    Date of Event
    December 12, 2017
    Report Date
    January 4, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169693814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE AND THEIR INSULIN PUMP ALARMED FAILED BATTERY AND LOW BATTERY ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 300, 189, 329, 274, 297, 273, 222, 160, 71, 232 AND 188 MG/DL. CUSTOMER¿S CURRENT BLOOD GLUCOSE VALUE WAS 107 MG/DL THE CUSTOMER WAS TREATED WITH PUMP, SYRINGE AND INJECTIONS. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS THIRSTY AND NOT FEELING WELL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR FAILED BATTERY AND UNDER DELIVERY. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10198 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 B6723NASJ 00643169693814

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other