BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4821228 · Received June 5, 2015

    Report

    Report Number
    3004209178-2015-62893
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    May 16, 2015
    Report Date
    May 18, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING THE REWIND DUE TO A CORRODED MOTOR HOME SWITCH. THE DISPLACEMENT TEST COULD NOT BE PERFORMED AND NO CHECK MOTOR ALARM COULD BE VERIFIED DUE TO THE MOTOR ERROR ALARM. THE INSULIN PUMP WAS RECEIVED WITH A SEVERELY SCRATCHED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, A CRACKED RESERVOIR TUBE LIP AND A MISSING END CAP STICKER.

    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

    THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR WHILE THE CUSTOMER WAS TRYING TO PRIME. THE INSULIN PUMP MADE A CRACKLING NOISE WHEN SHE TRIED TO PRIME THE INSULIN PUMP. SHE WAS UNABLE TO GET INTO THE MAIN MENU. THE CUSTOMER WAS UNABLE TO COMPLETE THE REWIND SEQUENCE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 190 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366032 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 16 YR