BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTO CODE

    MDR report key: 9226524 · Received October 23, 2019

    Report

    Report Number
    3008789114-2019-00054
    Event Type
    Injury
    Date Received
    October 23, 2019
    Date of Event
    September 30, 2019
    Report Date
    October 23, 2019
    Manufacturer
    OK BIOTECH COMPANY LTD
    Product Code
    NBW
    UDI-DI
    00384841518505
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 2:00PM AT THE END-USERS HOME. REPORTER STATED THAT THE END-USER FELT AS THOUGH HIS BLOOD GLUCOSE WAS LOW, SO HE ATTEMPTED TO PERFORM A BLOOD GLUCOSE TEST AND HIS PRODIGY METER WOULD NOT POWER ON. REPORTER STATED THAT THE END-USER HAD OATMEAL, WATER AND A GLUCERNA SHAKE PRIOR TO SEEKING MEDICAL ATTENTION. A NORMAL RESULT FOR HIM AT THAT TIME OF DAY IS AROUND 113-130 MG/DL. REPORTER STATED THAT THE END-USER THEN WENT TO AN URGENT CARE TO HAVE HIS BLOOD GLUCOSE TAKEN. REPORTER SAID HIS BLOOD GLUCOSE WAS 88 MG/DL WHEN THEY ARRIVED AT THE URGENT CARE BUT DUE TO HIS BLOOD GLUCOSE CONTINUING TO DROP THEY CALLED EMS TO TRANSPORT THE END-USER TO THE HOSPITAL. THE END-USER WAS GIVEN A GLUCOSE SHOT AT THE URGENT CARE WHILE WAITING FOR EMS TO ARRIVE. EMS ARRIVED ABOUT 30 MINUTES LATER. REPORTER STATED THAT HIS BLOOD GLUCOSE WAS CHECKED BY THE EMS BUT DOESN'T RECALL WHAT THE RESULT WAS. THE END-USER WAS GIVEN A GLUCOSE PILL AND A SHOT BY EMS. THE END-USER WAS AT THE HOSPITAL FOR ABOUT 5 HOURS AND HE WASN'T ADMITTED. ROUTINE TESTS WERE PERFORMED BY THE HOSPITAL AND ALL RESULTS WERE NORMAL. THE END-USER TAKES 74 UNITS OF LEVEMIR AT BEDTIME AND HAS A SLIDING SCALE FOR HIS NOVOLOG THAT GOES AS FOLLOWS: 70-150 MG/DL NO INSULIN 151-200 MG/DL 2 UNITS 201-300 MG/DL 6 UNITS. THE END-USER WAS TREATED AT (B)(6) MEDICAL CENTER LOCATED AT (B)(6). UPON DISCHARGE HE WAS INSTRUCTED TO FOLLOW UP WITH HIS PRIMARY CARE DOCTOR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019988 PRODIGY AUTO CODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH COMPANY LTD 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization