BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3251159 · Received July 29, 2013

    Report

    Report Number
    2032227-2013-03168
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    November 25, 2012
    Report Date
    July 12, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED ALL FUNCTIONAL TEST, INCLUDING PRIME, DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, AND EXCESSIVE NO DELIVERY ALARM TEST.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE HAD UNEXPLAINED HIGH BLOOD GLUCOSE. PARAMEDICS WHERE CALLED TO ASSIST CUSTOMER AT HOME FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 406 MG/DL WHEN THE PARAMEDICS ARRIVED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352201 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523PNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization