BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7885172 · Received September 18, 2018

    Report

    Report Number
    2032227-2018-29803
    Event Type
    Malfunction
    Date Received
    September 18, 2018
    Date of Event
    August 29, 2018
    Report Date
    December 3, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169507258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. MEDTRONIC, INC.

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED WITH BLANK DISPLAY FOLLOWED BY AN UNEXPECTED CONSTANT AUDIO TONE DUE TO MOISTURE DAMAGE AT ELECTRONIC ASSEMBLY. ALSO, MOISTURE DAMAGE MOTOR DURING VISUAL INSPECTION. UNABLE TO PERFORM OPERATING CURRENTS, SELF TEST, REWIND TEST AND DISPLACEMENT TEST DUE TO BLANK DISPLAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS VIBRATING WITHOUT AN ALARM OR ALERT. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 160 MG/DL. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728093 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS B5723NASJ 00643169507258

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR