BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4103587 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26431
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    July 26, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS, DEHYDRATION AND ACID. THE BLOOD GLUCOSE READING WAS OVER 600 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN AND INTRAVENOUS DRIP. SHE WAS WEARING THE INSULIN PUMP AT THE TIME OF HOSPITALIZATION. SHE REPORTED THAT SHE HAD KETONES, AND THAT SHE HAD TRIED TO TREAT MANUALLY BUT HER BLOOD GLUCOSE LEVELS WERE STILL ELEVATED. SHE REPORTED THAT THE INFUSION SET CANNULA WAS BENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581694 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization