BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2984068 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-91435
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    November 22, 2012
    Report Date
    February 15, 2013
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    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 INCLUDING THE DISPLACEMENT TEST. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING LOW BLOOD GLUCOSE OF 30S MG/DL. THE PARAMEDICS WERE CALLED AND TREATED HER BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED, AND IT SEEMS THAT THE INSULIN PUMP WAS FUNCTIONING AS DESIGNED. THE CALLER BELIEVED THAT SHE MIGHT MISCALCULATE THE CARBOHYDRATES COUNT. THE CUSTOMER ALSO MENTIONED THAT SHE PASSED OUT THE DAY BEFORE AND HER FAMILY FOUND HER. THE CUSTOMER STATED THAT THE RELATIVES HELPED HER TO BRING UP THE GLUCOSE LEVEL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86464 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention