BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4233545 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48889
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOWNLOAD HISTORY FILE SHOWS NO DATA FOR OCTOBER 2014. UNABLE TO VERIFY SUSPEND ANOMALY. UNIT PASSED THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST AND THE EXCESSIVE NO DELIVERY TEST. NO UNEXPECTED NO DELIVERY ALARM NOTED. THE SUSPEND FEATURE FUNCTIONS PROPERLY. UNIT WAS PROGRAMMED WITH SEVERAL BOLUSES AND MONITORED. THE UNIT CALCULATED THE ADDITIONAL BOLUS DELIVERIES AND WERE VERIFIED IN THE DAILY TOTAL SCREEN. UNIT THEN WAS PROGRAMMED WITH MULTIPLE BASAL PROFILES AND MONITORED FOR THREE DAYS. ALL BASAL PROFILES DELIVERED PROPERLY THEIR INDICATED AMOUNTS AND WERE VERIFIED IN THE DAILY TOTAL SCREEN. NO DELIVERY ANOMALY OR UNEXPECTED SUSPEND ANOMALY NOTED. UNIT HAD A MINOR SCRATCHED DISPLAY WINDOW, CRACKED RESERVOIR TUBE AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 397 MG/DL. IT WAS REPORTED THAT THE INSULIN PUMP OF THE CUSTOMER SUSPENDED ITSELF THREE TIMES DURING THE NIGHT WHILE SHE WAS SLEEPING. THE CUSTOMER ALSO REPORTED RECEIVING TWO NO DELIVERY ALARMS FROM THE INSULIN PUMP IN THE MORNING. THE CUSTOMER REPORTED TREATING WITH INSULIN PUMP. THE CUSTOMER DECLINED TO TROUBLESHOOT. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED SINCE THE CUSTOMER WAS PREGNANT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK-UP PLAN PER THE HEALTH CARE PROVIDER'S INSTRUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715775 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR