BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2870077 · Received December 12, 2012

    Report

    Report Number
    2032227-2012-08003
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    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

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. UNIT WAS RECEIVED WITH SCRATCHED DISPLAY WINDOW AND CRACKED BATTERY TUBE THREADS NOTED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PARAMEDICS WERE CALLED AND CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DKA. THE BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS 276 MG/DL. CALLER STATED THAT THE CUSTOMER HAD NAUSEA AND DIARRHEA PRIOR TO HOSPITALIZATION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization