BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAS

    MDR report key: 8580963 · Received May 5, 2019

    Report

    Report Number
    3004209178-2019-93031
    Event Type
    Injury
    Date Received
    May 5, 2019
    Date of Event
    March 1, 2019
    Report Date
    May 24, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169513860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO PARTIAL UNLOCKED J2 OR LCD KEYPAD CONNECTOR NOTED DURING VISUALLY INSPECT. UNABLE TO PERFORM ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT, OPERATING CURRENTS, UNEXPECTED RESTART, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST DUE TO BUTTONS NOT RESPONDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL IN THE RANGE OF 410 MG/DL. THE CUSTOMER STATED THAT THE BUTTONS HAD TO PRESS MULTIPLE TIMES. CUSTOMER WAS TREATED WITH INSULIN SYRINGES. CUSTOMER EXPERIENCED BLOOD GLUCOSE LEVEL OF 280, 240, 248 MG/DL. CUSTOMER STATED THAT THE TIME WAS ADVANCING. CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374165 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAS A4523LNASJ 00643169513860

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other FRN-UNK-RSVR, UNOMED INF SET