BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920031 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86490
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING BASIC OCCLUSION TEST DUE TO LOOSE/PROTRUDED DRIVE SUPPORT DISK. UNABLE TO VERIFY THE ERROR ALARMS DUE TO MOTOR ERROR ALARMS. THE DEVICE WAS RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS, AND MINOR SCRATCHED DISPLAY WINDOW.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE INSULIN PUMP HAD BEEN ALARMING WHILE TRYING TO PLACE RESERVOIR INTO THE DEVICE. DURING TROUBLESHOOTING IT WAS FOUND THAT THE DRIVE SUPPORT CAP WAS PROTRUDING FROM THE DEVICE. CUSTOMER STATES THEY HAD NOT DROPPED THE DEVICE OR TRIED TO PUSH THE DRIVE SUPPORT CAP INTO A RECESSED POSITION. ADVISED CUSTOMER TO DISCONNECT FROM THE INSULIN PUMP AND INFORMED THAT THE DEVICE ALARMING WAS DUE TO THE FORCE SENSOR BEING UNABLE TO DETECT THE RESERVOIR. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO HEALTHCARE PROVIDER'S INSTRUCTIONS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 98 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396492 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR