BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3251035 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-96134
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 5, 2013
    Report Date
    July 12, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST AS A RESULT OF A FAULTY FORCE SENSOR. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE PRIME ANOMALY. HOWEVER, THE MOTOR PASSED THE MOTOR TEST AND DISPLACEMENT TEST.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS EXPERIENCING HIGH BLOOD GLUCOSE OF 498MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD SETTINGS WERE CORRECT. ASSISTED THE CUSTOMER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. PERFORMED A HIGH PRESSURE TEST AND THE TEST FAILED. THE CALLER MENTIONED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER CALLED BACK AND STATED THAT HE WENT TO THE EMERGENCY ROOM BECAUSE HE DID NOT HAVE ANY INSULIN AND HIS GLUCOSE LEVEL WENT UP TO 598MG/DL. THE CUSTOMER'S BLOOD GLUCOSE WAS TREATED AND HE WAS RELEASED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351973 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization