BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4871489 · Received June 26, 2015

    Report

    Report Number
    3004209178-2015-68974
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 8, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO BUTTON ERROR ALARMS NOTED DURING TESTING. HOWEVER, THE PUMP HAD INTERMITTENT ESC, ACT AND DOWN BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO UNEXPECTED NUMBERS RAMPING/SCROLLING WERE NOTED DURING TESTING. NO MOISTURE DAMAGE WAS NOTED ON THE ELECTRONIC ASSEMBLY DURING VISUAL INSPECTION. THE PUMP HAD MINOR SCRATCHES ON THE LCD WINDOW, CRACKED BATTERY TUBE THREADS, A CRACKED BELT CLIP SLOT, AND A CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED BUTTON ERROR AFTER THE INSULIN PUMP MAY HAVE BEEN EXPOSED TO SWEAT. THE CUSTOMER'S BLOOD GLUCOSE WAS 98 MG/DL. THE CUSTOMER STATED THAT SHE WAS ABLE TO CLEAR THE ALARM, BUT THE INSULIN PUMP WOULD BEGIN TO ACT UP AS IF THE BUTTONS WERE BEING PRESSED. 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 AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413944 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 29 YR