BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7119281 · Received December 14, 2017

    Report

    Report Number
    2032227-2017-73505
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    August 9, 2017
    Report Date
    January 2, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169513884
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: THE INSULIN PUMP HAD BLANK DISPLAY DUE TO MOISTURE DAMAGE ON LCD BOARD. UNABLE TO PERFORM IDLE CURRENT TEST, RUN CURRENT TEST, SELF TEST, OFF NO POWER TEST, UNEXPECTED RESTART ERROR TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/COMPROMISED FORCE SENSOR TEST, EXCESSIVE NO DELIVERY TEST, DISPLACEMENT TEST OR VERIFY BATTERY OUT LIMIT ALARM DUE TO BLANK DISPLAY. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW AND CRACKED RESERVOIR TUBE LIP. (B)(4).

    Additional Manufacturer Narrative · 1

    PUMP HAD BLANK DISPLAY DUE TO MOISTURE DAMAGE ON LCD BOARD. UNABLE TO PERFORM IDLE CURRENT TEST, RUN CURRENT TEST, SELF TEST, OFF NO POWER TEST, UNEXPECTED ALARM ERROR TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIMETEST, EXCESSIVE NO DELIVERY TEST, DISPLACEMENT TEST OR VERIFY BATTERY OUT LIMIT ALARM DUE TO BLANK DISPLAY. PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THE DEVICE HAD ALARMED BATTERY OUT LIMIT ALARM AND HAD A BLANK DISPLAY. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONALS¿ INSTRUCTIONS. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. CUSTOMER AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895678 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 A5723LNAHJ 00643169513884

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR