BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3211969 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-95487
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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 INCLUDING THE DISPLACEMENT TEST. UNABLE TO CONFIRM THE NO DELIVERY ALARM. THE DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED. PLEASE SEE MEDWATCH REPORT # 3004209178-2013-95486.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE, AND THE CALL BECAME DISCONNECTED. ATTEMPTED TO CALL THE CUSTOMER SEVERAL TIMES WITH NO RESULTS. INITIALLY, THE CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE OF 229MG/DL, AND HIS BLOOD GLUCOSE WAS TREATED WITH MANUAL INJECTIONS. TROUBLESHOOTING WAS PERFORMED, AND THE CALLER STATED THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING MANUAL PRIME. ASSISTED THE CUSTOMER TO RUN A MANUAL PRIME AND THE INSULIN DID EXIT. PERFORMED THE DISPLACEMENT TEST AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311343 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization