BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5508588 · Received March 17, 2016

    Report

    Report Number
    3004209178-2016-91732
    Event Type
    Injury
    Date Received
    March 17, 2016
    Date of Event
    June 20, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    NO BATTERY OUT LIMIT ALARM NOTED. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. OFF NO POWER ALARM FUNCTION PROPERLY AND PASSED SELF TEST. NO UNEXPECTED BLANK DISPLAY NOTED. INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP, BROKEN BATTERY TUBE THREADS, MINOR SCRATCHED LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW, STAINED END CAP STICKER AND PEELING KEYPAD OVERLAY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE PLASTIC ON THE DEVICE WAS LIFTED AND PEELED OFF. CUSTOMER'S BLOOD GLUCOSE WAS 450 MG/DL. AFTER TROUBLESHOOTING, CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONALS' INSTRUCTIONS. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. CUSTOMER AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164728 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other