BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5657240 · Received May 16, 2016

    Report

    Report Number
    3004209178-2016-48622
    Event Type
    Malfunction
    Date Received
    May 16, 2016
    Date of Event
    April 23, 2016
    Report Date
    April 23, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: UNIT PASSED THE FUNCTIONAL TEST, INCLUDING THE SELF-TEST, UNEXPECTED RESTART ERROR TEST, DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, OFF NO POWER TEST AND EXCESSIVE NO DELIVERY TEST. UNIT WAS MONITORED FOR 24 HOURS, NO BLANK DISPLAY, BATTERY OUT OF LIMIT OR FAILED BATTERY ALARMS NOTED. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. NO UNEXPECTED LOW BATTERY OR OF NO POWER ALARMS NOTED. NO C13 ISOLATION TAPE DAMAGE NOTED ON LCD BOARD. NO COSMETIC DAMAGE NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THE INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER'S BLOOD GLUCOSE AT TIME OF INCIDENT WAS 192 MG/DL. THE ALARM AND POSSIBLE CAUSES WAS EXPLAINED TO THE CUSTOMER. THE CUSTOMER WAS ADVISED TO INSERT NEW BATTERY THE DISPLAY DID RETURN. CUSTOMER STATED THE PUMP KEPT COMING BACK WITH BATTERY OUT LIMIT AND FAILED BATTERY TEST EVEN INSERTED A NEW BATTERY. THE CUSTOMER WAS ADVISED THAT SOMETHING MUST BE GOING ON INTERNALLY AND IT IS BEST TO REPLACE THE PUMP. THE CUSTOMER WAS ADVISED THAT WE WILL SEND PACKS OF BATTERIES WITH THE PUMP ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310766 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR