BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM

    MDR report key: 10564824 · Received September 21, 2020

    Report

    Report Number
    9616936-2020-00002
    Event Type
    Injury
    Date Received
    September 21, 2020
    Date of Event
    August 3, 2020
    Report Date
    August 4, 2020
    Manufacturer
    APEX BIOTECHNOLOGY CORP.
    Product Code
    NBW
    UDI-DI
    00015482570057
    PMA / PMN Number
    K113098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FROM IMPORTER (ARKRAY USA INC,, HEREAFTER : ARKRAY). ARKRAY NOTIFIED THE MANUFACTURER (APEX BIOTECHNOLOGY CORP., HEREAFTER: APEXBIO) ON 25 AUG 2020 THAT THEY HAVE RECEIVED A CUSTOMER COMPLAINT WHICH WAS A MDR. ARKRAY RECEIVED THE COMPLAINED METER AND TEST STRIP (1 PIECE) AND PERFORMED TESTS. RESULTS WERE PASS. INVESTIGATION FROM MANUFACTURER (APEXBIO): APEXBIO PERFORMED FUNCTIONAL TEST TO THE RETURNED METER. ALL TESTS WERE PASS. APEXBIO PERFORMED VENOUS BLOOD TEST AND CONTROL SOLUTION TEST FOR RETURNED METER AND RETAIN STRIPS OF COMPLAINED LOT OF TEST STRIP. RESULTS WERE PASS. APEXBIO PERFORMED ADDITIONAL MOISTURE TEST TO THE DESICCANT IN STRIP BOTTLE. RESULTS WERE ACCEPTABLE.

    Description of Event or Problem · 1

    CUSTOMER'S WIFE WAS CALLING TO REPORT THAT THE METER WAS READING TOO HIGH. READING IS TOO HIGH BASED ON SYMPTOMS DISPLAYED AND CALLER STATED IF READING WAS ACCURATE, CUSTOMER WOULDN'T HAVE BEEN DISPLAYING SYMPTOMS. PATIENT WAS EATING LUNCH AND TOOK INSULIN ON HIS PUMP. THEN HE CALLED TO HIS WIFE AND ASKED FOR HELP AS HE WAS EXPERIENCING SEVERE HYPOGLYCEMIC SYMPTOMS AND HAVING A HARD TIME TALKING. HE WAS THEN CHECKED ON THE EXPRESSION METER AND THE READING WAS 50. HE WAS THEN CHECKED ON HIS BAYER METER AND THE READING WAS 31. HE WAS GIVEN JUICE AND GLUCOSE GEL AFTER 15 MINUTES HE WAS STILL VERY LOW, AND THE PARAMEDICS WERE CALLED. HE WAS GIVEN MORE GLUCOSE GEL FROM THEM AND IT TOOK TWO HOURS TO GET HIS BLOOD SUGAR UP. HE WAS NOT TAKEN TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028835 GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM NBW APEX BIOTECHNOLOGY CORP. 571100 B4S1911009 00015482570057

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R