BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY

    MDR report key: 3370869 · Received September 11, 2013

    Report

    Report Number
    3008789114-2013-00016
    Event Type
    Injury
    Date Received
    September 11, 2013
    Date of Event
    June 16, 2013
    Report Date
    June 25, 2013
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THAT ON (B)(6) 2013, AT 6AM, MEDICS HAD TO BE CALLED FOR MEDICAL ATTENTION. PT WOKE UP TO TEST AT 4AM AND RECEIVED READING OF 470MG/DL. HE GAVE INSULIN AND WENT BACK TO BED. PT WOKE UP, GAVE MORE INSULIN AND WENT BACK TO BED. HIS WIFE LATER FOUND HIM UNRESPONSIVE AT 6:30AM. PER REPORT, MEDICS WERE CALLED ABOUT AN HOUR LATER AND THEIR READINGS WERE UNK TO PT. EMT GAVE PT A SYRINGE FULL OF LIQUID TO SWALLOW, AND HIS WIFE HAVE HIM SUGAR SYRUP AND A GLUCOSE SHOT. PER INITIAL CALL, PT'S LAST TEST RESULTS: (B)(6) 2013, 123MG 4:00AM; (B)(6) 2013, 190MG, 5:10PM; (B)(6) 2013, 390MG, 5:00PM; (B)(6) 2013, 97 MG, 9:30PM; (B)(6) 2013, 490 MG, 4:30 AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456240 PRODIGY PRODIGY AUTOCODE NBW OK BIOTECH CO., LTD. 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention