BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTO CODE

    MDR report key: 9670785 · Received February 5, 2020

    Report

    Report Number
    3008789114-2020-00004
    Event Type
    Injury
    Date Received
    February 5, 2020
    Date of Event
    January 17, 2020
    Report Date
    February 5, 2020
    Manufacturer
    OK BIOTECH COMPANY LTD
    Product Code
    NBW
    UDI-DI
    00384841518505
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 6:00PM AT HOME. CALLER STATED THAT THE END-USER TESTED HER BLOOD GLUCOSE AND RECEIVED A RESULT OF 235MG/DL. A NORMAL RESULT FOR THAT TIME OF DAY IS USUALLY AROUND 130-140MG/DL. THE END-USER TOOK HER 15 UNIT OF LANTUS BASED ON HER RESULT. ABOUT 45 MINUTES LATER THE END-USER WAS SLURRING HER WORDS AND WAS UNSTABLE I.E. FALLING. EMS WERE CALLED. NO FOOD DRINK OR MEDICATION WAS CONSUMED WHILE WAITING FOR EMS TO ARRIVE. EMS ARRIVED WITHIN 2 MINUTES AND TESTED THE END-USERS BLOOD GLUCOSE WITH THEIR METER AND GOT A RESULT OF 35MG/DL. EMS GAVE THE END-USER A GLUCOSE SOLUTION BY MOUTH. EMS DID NOT TRANSFER THE END-USER TO THE HOSPITAL. PRIOR TO THE EMS LEAVING THEY PERFORMED ANOTHER BLOOD GLUCOSE TEST WITH THEIR METER AND GOT A RESULT OF 85MG/DL AND ADVISED THE END-USER TO FOLLOW UP WITH HER PRIMARY DOCTOR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134683 PRODIGY AUTO CODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH COMPANY LTD 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR ASPIRIN| GLIPIZIDE| LANTUS| LOSARTAN| LYRICA PREGABALIN| NOVOLIN| PANTOPRAZOLE| TRAMADOL| ZOLPIDEM