BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3200276 · Received July 1, 2013

    Report

    Report Number
    2032227-2013-02667
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    November 29, 2012
    Report Date
    June 19, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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

    A PHONE CALL WAS MADE TO THE CUSTOMER IN ORDER TO FOLLOW UP ON A PREVIOUS CALL SHE HAD MADE FOR HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT SHE WENT TO THE EMERGENCY ROOM DUE TO DIABETIC KETOACIDOSIS. THE CUSTOMER DID NOT KNOW WHAT THE BLOOD GLUCOSE READING WAS AT THE TIME. THE CUSTOMER WAS TOLD THAT SHE HAD AN INFECTION THAT CONTRIBUTED TO THE ELEVATED BLOOD GLUCOSE LEVELS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298411 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization