BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5251916 · Received November 25, 2015

    Report

    Report Number
    2032227-2015-69663
    Event Type
    Injury
    Date Received
    November 25, 2015
    Date of Event
    September 10, 2015
    Report Date
    November 10, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE FUNCTIONAL TESTS INCLUDING DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, AND EXCESSIVE NO DELIVERY ALARM TESTS. MULTIPLE BOLUSES WERE PROGRAM AND DELIVERED. ALL BOLUSES WERE DELIVERED AND PROPERLY RECORDED IN BOLUS HISTORY AND PROPERLY RECORDED IN DOWNLOAD HISTORY REPORT. NO DELIVERY ANOMALY WAS NOTED DURING TESTING. DEVICE FUNCTIONED PROPERLY. DEVICE HAD MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE LIP, BROKEN BELT CLIP SLOT, AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE IN THE 400 MAD 500 MG/DL RANGE. BLOOD GLUCOSE AT THE TIME OF THE CALL WAS 227 MG/DL. NO ISSUES WITH SET, INSULIN OR SETTINGS WERE FOUND DURING TROUBLESHOOTING BUT THE CUSTOMER STATED THAT THE BOLUS HISTORY WAS INCORRECT AS IT WAS MISSING A BOLUS AND ALSO, SHE DECLINED TO CHECK THE CANNULA. THE INSULIN PUMP WAS REPLACED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779319 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other