BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3883686 · Received June 19, 2014

    Report

    Report Number
    2032227-2014-03065
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. DRIVE SUPPORT CAP WAS INSPECTED AND NO ANOMALY WAS NOTED.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT HE HAD HIGH BLOOD GLUCOSE AND KETOACIDOSIS. CUSTOMER STATED THAT THE PARAMEDICS WERE CALLED AND HE WAS TAKEN TO THE HOSPITAL. THE BLOOD GLUCOSE READING WAS 301 MG/DL WHEN THE PARAMEDICS ARRIVED. CUSTOMER STATED THAT HE HAD SHORT TERM MEMORY ISSUES. CUSTOMER ALSO STATED THAT HIS INSULIN PUMP DRIVE SUPPORT IS FLUSH. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360206 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization