BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8623280 · Received May 20, 2019

    Report

    Report Number
    2032227-2019-04372
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    May 6, 2019
    Report Date
    June 17, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169507241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. 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 FLATTENED ESC AND ACT BUTTON DOME SWITCH. NO BUTTON ERROR ALARM DURING TESTING. NO UNLOCKED J2 OR LCD KEYPAD CONNECTOR. DEVICE PASSED SELF TEST.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP¿S BUTTON HAD HARD TO PRESS. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 106 MG/DL. CUSTOMER REPORTED THAT ACT BUTTON WAS HARD TO PRESS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418285 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAP PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP B5723NAPJ 00643169507241

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR