BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8644010 · Received May 27, 2019

    Report

    Report Number
    2032227-2019-07506
    Event Type
    Malfunction
    Date Received
    May 27, 2019
    Date of Event
    March 8, 2019
    Report Date
    May 27, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169513891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH BROKEN RESERVOIR TUBE LIP. A TEST RESERVOIR WAS INSTALLED AND DID NOT LOCK IN PLACE DUE TO COMPLETE BROKEN RESERVOIR TUBE LIP. A TEST RESERVOIR WAS INSTALLED AND DID NOT LOCK IN PLACE DUE TO COMPLETE BROKEN RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE TOP OF THE RESERVOIR COMPARTMENT WAS FALLING OFF. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE RESERVOIR WAS ABLE TO LOCK INTO PLACE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436767 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAL PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAL A5723LNALJ 00643169513891

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR