BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6182492 · Received December 16, 2016

    Report

    Report Number
    2032227-2016-50521
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    November 20, 2016
    Report Date
    November 21, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT PASSED FUNCTIONAL TEST INCLUDING DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, FORCE SYSTEM SENSOR AND EXCESSIVE NO DELIVERY TESTS. MULTIPLE BOLUSES WERE DELIVERED AND PROPERLY RECORDED IN BOLUS HISTORY AND DAILY TOTALS. UNIT FUNCTIONED PROPERLY. UNIT RECEIVED WITH MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, AND CRACKED BATTERY TUBE THREADS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL OF HAVING HIGH BLOOD GLUCOSE OF 470MG/DL AND BOLUS ISSUES. CUSTOMER TREATED WITH A BOLUS. TROUBLESHOOTING FOUND THAT THE HIGH PRESSURE TEST FAILED AND THE PUMP CLOCK WAS OFF BY 1 HOUR. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER THEIR DOCTOR'S INSTRUCTION. THE CUSTOMER WAS ALSO 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
    834124 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other