BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3132335 · Received May 29, 2013

    Report

    Report Number
    2032227-2013-02151
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 3, 2013
    Manufacturer
    MEDTRONIC MINIMED
    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

    THE INSULIN PUMP WAS RECEIVED WITH CRACKED AND BLEEDING DISPLAY WINDOW. UNABLE TO PERFORMED OCCLUSION, PRIME, AND NO DELIVERY TESTS DUE TO DISPLAY ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD UNEXPLAINED HIGH BLOOD GLUCOSE AND DKA. PARAMEDICS WERE CALLED AND CUSTOMER WAS HOSPITALIZED. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME THE PARAMEDICS ARRIVED WAS OVER 785 MG/DL. CALLER STATED THAT THE CUSTOMER WAS VOMITING AND SHAKING REALLY BAD AT EMERGENCY ROOM. CALLER STATED THAT THE CUSTOMER HAD AN INFECTION IN HIS BLOOD AND THAT THE INSULIN PUMP WAS BROKEN IT ONLY HAD TWO BLACK LINES ON THE DISPLAY WINDOW. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235368 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization