BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 6126601 · Received November 23, 2016

    Report

    Report Number
    2032227-2016-46012
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    October 26, 2016
    Report Date
    November 23, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED WITH THE INITIAL MEDWATCH REPORT. THE ADDITIONAL INFORMATION HAS BEEN PROVIDED WITH THIS REPORT.

    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

    ADDITIONAL INFORMATION WAS RECEIVED TO CLARIFY THAT THE CUSTOMER WAS ON PUMP THERAPY AT THE TIME OF THE REPORTED HOSPITALIZATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE WAS HOSPITALIZED FOR A HIGH BLOOD GLUCOSE OF 600 MG/DL AND DIABETIC KETOACIDOSIS. THE DATE OF THE HOSPITALIZATION WAS (B)(6) 2016. NO FURTHER DETAILS WERE PROVIDED REGARDING THE CUSTOMER'S TREATMENT. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777385 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization