BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4062065 · Received September 4, 2014

    Report

    Report Number
    2032227-2014-14397
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED BY CUSTOMER'S DAUGHTER THAT CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. IT WAS REPORTED THAT CUSTOMER WAS HOSPITALIZED ON (B)(6) 2014 WITH BLOOD GLUCOSE OF 600 MG/DL. CUSTOMER WAS WEARING INSULIN PUMP AT THE TIME OF HOSPITALIZATION. CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF CALL WAS 118 MG/DL. WHILE ATTEMPTING TO TROUBLESHOOT INSULIN PUMP FOR HIGH BLOOD GLUCOSE, EXCESSIVE NO DELIVERY ALARM WAS RECEIVED. CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541666 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization