BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3231464 · Received July 17, 2013

    Report

    Report Number
    2032227-2013-02933
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH UNRESPONSIVE BUTTON DUE TO CORRODED KEYPAD TRACES. NO RAMPING NUMBERS NOTED. UNABLE TO PERFORM FUNCTIONAL TEST INCLUDING DISPLACEMENT, PRIME, BASIC OCCLUSION, OCCLUSION, AND NO DELIVERY TEST DUE TO UNRESPONSIVE BUTTONS. DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS OVER 600 MG/DL. CUSTOMER STATED THAT SHE HAD DIABETIC DEHYDRATION PRIOR TO HOSPITALIZATION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330602 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization