BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4811191 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-61289
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 11, 2015
    Report Date
    May 11, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW AND A BROKEN BELT CLIP SLOT.

    Additional Manufacturer Narrative · 1

    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 HAD A FROZEN DISPLAY. THE CUSTOMER STATED THAT SHE CHANGED THE BATTERY 3 TIMES, BUT THE INSULIN PUMP KEPT GOING BACK TO THE SAME SCREEN. THE CUSTOMER STATED THAT SHE WAS CHANGING OUT HER INSULIN PUMP AND WAS AT THE FILL TUBING STEP WHEN IT PROMPTED HER TO CONFIRM WHETHER SHE WAS DISCONNECTED FROM THE DEVICE. SHE TRIED TO SELECT "YES," BUT THE DISPLAY WAS FROZEN. THE CUSTOMER'S MOST RECENT BLOOD GLUCOSE WAS 115 MG/DL. SHE NOTED THAT THE TIME WAS ADVANCING ON THE DISPLAY. THE CUSTOMER DID NOT OBSERVE ANY SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUES. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED TO REPLACE THE INSULIN PUMP AND DECLINED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356679 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR