BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143004 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30217
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED ALL FUNCTIONAL TESTING INCLUDING THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY AND DISPLACEMENT TESTS. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT DISPLAY WINDOW CORNERS AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A HOSPITALIZATION FOR HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 475 MG/DL. CUSTOMER REPORTED THAT THE PRIMARY HEALTH PROVIDER INFO HIM THAT THE INSULIN PUMP HAD FAILED. CUSTOMER WAS NOT IN AN ACCIDENT. THE BLOOD GLUCOSE READING AT THE TIME OF THE REPORT WAS 154 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603725 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization