BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3790162 · Received May 5, 2014

    Report

    Report Number
    2032227-2014-02245
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 14, 2014
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. UNIT WAS RECEIVED WITH SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE AND DKA. CALLER STATED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS 385 MG/DL, SHE GAVE HIM AN INJECTION AND THE BLOOD GLUCOSE READING WAS 125 MG/DL AT THE HOSPITAL. CALLER STATED THAT THE CUSTOMER'S INSULIN PUMP WAS ALARMING NO DELIVERY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267101 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization