BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3990547 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-90865
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST, AND THE EXCESSIVE NO DELIVERY TEST. THE INSULIN PUMP WAS PROGRAMMED WITH SEVERAL BOLUSES AND MONITORED. ALL BOLUSES DELIVERED PROPERLY AND WERE LISTED IN THE BOLUS HISTORY SCREEN. THE INSULIN PUMP CALCULATED THE ADDITIONAL BOLUS DELIVERIES AND WERE VERIFIED IN THE DAILY TOTAL SCREEN. THE INSULIN PUMP WAS THEN PROGRAMMED WITH MULTIPLE BASAL PROFILES AND MONITORED. ALL BASAL PROFILES DELIVERED THEIR INDICATED AMOUNTS PROPERLY AND WERE VERIFIED IN THE DAILY TOTAL SCREEN. NO DELIVERY ANOMALY, DAILY TOTAL ANOMALY, BASAL ANOMALY OR BOLUS ANOMALY NOTED. THE INSULIN PUMP HAD A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER'S FATHER REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS HAVING A DELIVERY ANOMALY AND THAT IT WAS UNDER DELIVERING. THE CUSTOMER'S BLOOD GLUCOSE WAS 120 MG/DL, THEN 115 MG/DL. DURING TROUBLESHOOTING, THE INSULIN PUMP PASSED THE SELF TEST, THE FIXED PRIME TEST, AND THE 5 UNITS BOLUS TEST. THE BASAL AND BOLUS SETTINGS WERE CHECKED AND WERE FOUND TO BE CORRECT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468275 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722WWS

    Patients

    Seq Age Sex Outcome Treatment
    1