BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM

    MDR report key: 10723951 · Received October 23, 2020

    Report

    Report Number
    9616936-2020-00003
    Event Type
    Injury
    Date Received
    October 23, 2020
    Date of Event
    July 13, 2020
    Report Date
    August 3, 2020
    Manufacturer
    APEX BIOTECHNOLOGY CORP.
    Product Code
    NBW
    UDI-DI
    00015482570057
    PMA / PMN Number
    K113098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 4 AUG 2020 THAT THEY HAVE RECEIVED A CUSTOMER COMPLAINT WHICH WAS A MDR. ARKRAY RECEIVED THE COMPLAINED METER AND TEST STRIP (1 PIECE) ON 21 AUG 2020 AND PERFORMED TESTS. RESULTS WERE PASS. INVESTIGATION FROM MANUFACTURER (APEXBIO): APEXBIO PERFORMED VENOUS BLOOD TEST AND CONTROL SOLUTION TEST FOR RETAIN STRIPS OF COMPLAINED LOT OF TEST STRIP AFTER RECEIVING ARKRAY'S NOTIFICATION. RESULTS WERE PASS. APEXBIO RECEIVED RETURNED METER ON 2 SEP 2020 AND PERFORMED FUNCTIONAL TEST, VENOUS BLOOD TEST AND CONTROL SOLUTION TEST FOR THE RETURNED METER WITH SPECIFIC LOT OF RETAIN STRIPS. RESULTS WERE PASS. APEXBIO PERFORMED ADDITIONAL MOISTURE TEST TO THE DESICCANT IN STRIP BOTTLE. RESULTS WERE ACCEPTABLE.

    Description of Event or Problem · 1

    CALLER GOT READY FOR DAY, AND THEN SHE STARTED SHAKING, AND HAVING HYPOGLYCEMIA SYMPTOMS, SO SHE CHECKED HER BLOOD GLUCOSE AND RECEIVED A READING OF 145. SHE DID A CONTROL SOLUTION TEST THAT WAS IN RANGE. SHE CALLED HER GRANDDAUGHTER AND CALLED 911 AND THE EMS CAME ABOUT 15 MINUTES LATER. THEY CHECKED HER BLOOD GLUCOSE AND IT WAS 97, SO THEY TREATED HER WITH A GLUCOSE IV AND WITHIN TWO MINUTES SHE STOPPED SHAKING. SHE THEN HAD HER GRANDDAUGHTER TAKE HER TO THE HOSPITAL TO GET CHECKED OUT. AT THE HOSPITAL, A FEW TESTS WERE PERFORMED, AND THEY RELEASED HER WITHOUT ANY TREATMENT OF ANY SORT. CALLER ALSO STATED SHE HAS NEVER FELT LIKE THIS BEFORE OR EXPERIENCED THIS BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193278 GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM NBW APEX BIOTECHNOLOGY CORP. 571100 B4S1907012 00015482570057

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R