BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 9303403 · Received November 11, 2019

    Report

    Report Number
    2032227-2019-115438
    Event Type
    Injury
    Date Received
    November 11, 2019
    Date of Event
    October 15, 2019
    Report Date
    November 11, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169933170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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 VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVELS 451 MG/DL. CUSTOMER HAD BLOOD GLUCOSE LEVELS OF 140, 173, 116, 180 AND 289 MG/DL. CUSTOMER WAS TREATED WITH INSULIN PUMP. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STATED THERE WAS NO AIR BUBBLES AND LEAK. CUSTOMER DID NOT ALLEGE INSULIN PUMP FOR UNDER DELIVERING. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR THE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101630 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS A6723LNASJ 00643169933170

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other