BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3930610 · Received July 12, 2014

    Report

    Report Number
    3004209178-2014-86838
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    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

    THE INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM. THE INSULIN PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, CRACKED BELT CLIP SLOT AND CRACKED LCD WINDOW.

    Description of Event or Problem · 1

    CUSTOMER CALLED STATING THAT HER INSULIN PUMP HAS CRACKS AND SHOWS BUTTON ERROR. THE DEVICE KEEPS BEEPING EVERY COUPLE OF MINUTES. CUSTOMER TRIED TO CLEAR THE ALARM BUT IT SEEMS LIKE THE BUTTONS ARE NOT WORKING. CUSTOMER'S BLOOD GLUCOSE LEVEL IS 129 MG/DL. CUSTOMER STATED SHE DROPPED THE DEVICE. SHE WAS ADVISED THAT THE DEVICE WILL NEED TO BE REPLACED, AND TO DISCONTINUE USE OF THE DEVICE AND REVERT TO HER BACK UP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408841 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR