BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 3895446 · Received June 25, 2014

    Report

    Report Number
    2032227-2014-03359
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. PLEASE SEE MEDWATCH REPORT #3004209178-2014-86047.

    Description of Event or Problem · 1

    CUSTOMER CALLED IN TO REPORT A HOSPITALIZATION ON (B)(6) 2014 DUE TO HIGH BLOOD GLUCOSE CAUSED BY BENT CANNULA ON THE INFUSION SET. BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS BETWEEN 550 MG/DL AND 650 MG/DL. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE HOSPITALIZATION. CUSTOMER MENTIONED THAT 2 OF THE SENSOR CANNULAS HAD BENT DURING INSERTION. CURRENT BLOOD GLUCOSE READING IS 200 MG/DL. REPLACEMENT SENSORS SENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370022 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A B194U

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization