BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM

    MDR report key: 11798631 · Received May 10, 2021

    Report

    Report Number
    1832816-2021-00007
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    March 13, 2021
    Report Date
    March 30, 2021
    Manufacturer
    APEX BIOTECHNOLOGY CORP.
    Product Code
    NBW
    UDI-DI
    00015482570057
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER RETURNED METER AND ONE TEST STRIP OF SPECIFIED LOT. THE RETURNED METER WAS TESTED WITH ONE TEST STRIP OF SPECIFIED LOT AND RETAIN STRIPS OF SPECIFIED LOT AND BLOOD PASSED TESTING. NO FAILURE DETECTED. METER WILL BE RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. THIS FOLLOW-UP REPORT IS DELAYED BECAUSE THE ORIGINAL MDR WAS SUBMITTED INCORRECTLY, AND WE NEEDED TO WAIT FOR THE FDA TO DELETE THE INCORRECT REPORT TO SUBMIT THE CORRECTED REPORT. PLEASE SEE THE ATTACHED CORRESPONDENCE WITH THE FDA FOR MORE INFORMATION.

    Description of Event or Problem · 0

    PATIENT SAID SHE TOOK A READING AND RECEIVED 120, AND THEN TOOK ANOTHER READING AND RECEIVED 300. THESE READINGS WERE WITHIN 10 MINUTES. THIS OCCURRED SATURDAY, (B)(6) 2021 IN THE EVENING. SHE SAID SHE DIDN'T HAVE ANY SYMPTOMS. SHE THOUGHT SHE WAS OKAY. SHE DIDN'T EAT ANYTHING TO HELP LOWER HER BLOOD SUGAR. SHE DIDN'T TAKE ANY INSULIN. SHE DIDN'T HAVE ANY FOOD, BEVERAGES, OR MEDICINE TWO HOURS PRIOR. LATER, SHE WENT TO SLEEP LATER FOR A WHILE. HER HUSBAND TRIED TO WAKE HER UP, BUT SHE WASN'T RESPONDING TO HIM. HER HUSBAND CALLED THE PARAMEDICS AROUND 3 OR 4 AM. SHE SAID THE PARAMEDICS USED THEIR METER TO TEST HER GLUCOSE AND THEY RECEIVED 42. THEY GAVE HER SOMETHING TO HELP INCREASE HER GLUCOSE. SHE STARTED TO COME BACK TO HER NORMAL SELF AFTER THEY TREATED HER. SHE STORES METER IN HER BEDROOM. CUSTOMER IS NOT RECEIVING OXYGEN THERAPY. SHE DOESN'T HAVE TROUBLE GETTING A SAMPLE OF BLOOD AND SEALS STRIP BOTTLE TIGHTLY AND IMMEDIATELY AFTER OPENING. USES FINGERTIP AS A TESTING SITE. USES ALCOHOL TO CLEANSE TESTING SITE AND ALLOWS HANDS TO DRY THOROUGHLY. OPENED TEST STRIP BOTTLE LAST MONTH. VERIFIED THERE'S NO CHANGES IN DIET, EXERCISE OR STRESS LEVELS. VERIFIED SHE CHANGE THE LANCET EVERY TIME SHE TESTS. NORMAL GLUCOSE RANGE IS ABOUT 90-150. REPLACED METER, STRIPS AND SENT RL.

    Additional Manufacturer Narrative · 1

    COMPLAINT PRODUCTS WERE NOT RETURNED FOR EVALUATION. RETAIN STRIPS OF SPECIFIED LOT WERE TESTED WITH REFERENCE METER AND PASSED TESTING WITH NO FAILURES DETECTED. IF EITHER METER OR STRIPS IS RETURNED, ARKRAY WILL EVALUATE THE PRODUCT AND FILE A FOLLOW-UP REPORT. THIS IS A NEW REPORT FOR 1832816-2021-00007. ON MARCH 27, 2021, THIS REPORT WAS ORIGINALLY SUBMITTED, HOWEVER, OUR ORGANIZATION INADVERTENTLY USED "MFR REPORT #" FIELD AND WE SHOULD HAVE USED THE "UF/IMPORTER REPORT #" FIELD AS MY ORGANIZATION IS THE IMPORTER OF THIS DEVICE.

    Description of Event or Problem · 1

    PATIENT SAID SHE TOOK A READING AND RECEIVED 120, AND THEN TOOK ANOTHER READING AND RECEIVED 300. THESE READINGS WERE WITHIN 10 MINUTES. THIS OCCURRED SATURDAY, (B)(6) 2021 IN THE EVENING. SHE SAID SHE DIDN'T HAVE ANY SYMPTOMS. SHE THOUGHT SHE WAS OKAY. SHE DIDN'T EAT ANYTHING TO HELP LOWER HER BLOOD SUGAR. SHE DIDN'T TAKE ANY INSULIN. SHE DIDN'T HAVE ANY FOOD, BEVERAGES, OR MEDICINE TWO HOURS PRIOR. LATER, SHE WENT TO SLEEP LATER FOR A WHILE. HER HUSBAND TRIED TO WAKE HER UP, BUT SHE WASN'T RESPONDING TO HIM. HER HUSBAND CALLED THE PARAMEDICS AROUND 3 OR 4 AM. SHE SAID THE PARAMEDICS USED THEIR METER TO TEST HER GLUCOSE AND THEY RECEIVED 42. THEY GAVE HER SOMETHING TO HELP INCREASE HER GLUCOSE. SHE STARTED TO COME BACK TO HER NORMAL SELF AFTER THEY TREATED HER. SHE STORES METER IN HER BEDROOM. CUSTOMER IS NOT RECEIVING OXYGEN THERAPY. SHE DOESN'T HAVE TROUBLE GETTING A SAMPLE OF BLOOD AND SEALS STRIP BOTTLE TIGHTLY AND IMMEDIATELY AFTER OPENING. USES FINGERTIP AS A TESTING SITE. USES ALCOHOL TO CLEANSE TESTING SITE AND ALLOWS HANDS TO DRY THOROUGHLY. OPENED TEST STRIP BOTTLE LAST MONTH. VERIFIED THERE'S NO CHANGES IN DIET, EXERCISE OR STRESS LEVELS. VERIFIED SHE CHANGE THE LANCET EVERY TIME SHE TESTS. NORMAL GLUCOSE RANGE IS ABOUT 90-150. REPLACED METER, STRIPS AND SENT RL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698942 GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW APEX BIOTECHNOLOGY CORP. 571100 B4S1907012 00015482570057

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R