BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3990342 · Received August 7, 2014

    Report

    Report Number
    3004209178-2014-91293
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    June 15, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD MOISTURE DAMAGE ON KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. ALL BUTTONS FUNCTION PROPERLY. IT WAS NOTED DURING VISUAL INSPECTION INSULIN PUMP HAD A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON DISPLAY WINDOW, MISSING END CAP STICKER AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A BUTTON ERROR ALARM. HE STATED THAT THIS ISSUE HAD BEGUN A FEW WEEKS PRIOR AND WOULD NORMALLY BE RESOLVED WITH A BATTERY CHANGE, AND THAT THE BUTTONS WOULD BE LESS STICKY. HE ALSO REPORTED THAT DURING PRIMING, INSULIN CONTINUED TO COME OUT AND THAT HE WAS UNABLE TO COMPLETE THE PRIME PROCESS. HE STATED THAT THE DOME LABEL HAD FALLEN OFF. THE BLOOD GLUCOSE READING WAS 126 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464413 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR