BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8883670 · Received August 12, 2019

    Report

    Report Number
    2032227-2019-45473
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    August 2, 2019
    Report Date
    August 12, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169933149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTONS WERE STICK AND HAD SCRATCHES ON THE SCREEN THAT AFFECT ABILITY VIEW. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED INSULIN PUMP HAD DIMINISHED BATTERY LIFE AND INSULIN PUMP REJECTS NEW BATTERY SEVERAL TIMES. CUSTOMER ALSO REPORTED THAT INSULIN PUMP HAD ERROR CODES AND UNEXPLAINED NO DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678334 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAH PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAH A6723LNAHJ 00643169933149

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR