BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3841761 · Received May 30, 2014

    Report

    Report Number
    2032227-2014-02687
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 16, 2016
    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

    THE PUMP PASSED THE VOLUME ACCURACY TESTS. CORROSION WAS FOUND ON THE KEYPAD TRACES.

    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.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A BUTTON ERROR ON HER INSULIN PUMP AND A HOSPITALIZATION FROM LOW BLOOD. CUSTOMER WOULD GO LOW WHILE SLEEPING. BLOOD GLUCOSE READING WAS 32 MG/DL WHEN THE PATIENT WAS AT HOME, 40 MG/DL WHEN THE PARAMEDICS ARRIVED AND 120 MG/DL AT THE TIME OF ADMISSION AT THE HOSPITAL. CURRENT BLOOD GLUCOSE READING IS 120 MG/DL. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318864 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization