BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM

    MDR report key: 18910618 · Received March 15, 2024

    Report

    Report Number
    9616936-2024-00001
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    February 8, 2024
    Report Date
    February 29, 2024
    Manufacturer
    APEX BIOTECHNOLOGY CORP.
    Product Code
    NBW
    UDI-DI
    00015482570101
    PMA / PMN Number
    K113098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION PROVIDED BY IMPORTER (ARKRAY FACTORY USA, INC.): ARKRAY ATTEMPTED TO GATHER STRIP LOT INFORMATION DURING INITIAL CALL AND REQUEST THE RETURN OF SUBJECT METER AND TEST STRIPS. ACTURAL PRODUCTS WERE NOT RETURNED FOR TESTING AND LOT NUMBER IS NOT KNOWN SO RETENTION SAMPLES COULD NOT BE TESTED. IF EITHER STRIPS OR METER ARE RETURNED, ARKRAY WILL EVALUATE THE PRODUCT AND FILE A FOLLOW-UP REPORT. MANUFACTURER NARRATIVE: 1. COMPLAINED METER WAS PACKED AS A KIT PRODUCT WHICH CONTAINED BLOOD GLUCOSE TEST STRIP LOT B4S2203013 AND WAS DELIVERED TO ARKRAY ON MAY 2022. 2. IN-HOUSE CLINICAL CAPILLARY BLOOD TEST (FINGER TIP BLOOD TEST) FOR RETAIN METER AND RETAIN SAMPLE OF TEST STRIP LOT B4S2203013 ARE CONDUCED. THE RESULTS ARE PASSED WITH SPECIFIED SPECIFICATIONS. PLEASE REFER TO THE ATTACHMENT "24000014-S8 FINGER TIP TEST RESULT". 3. ROOT CAUSE OR POSSIBLE REASON FOR THIS COMPLAINT HAS NOT BEEN IDENTIFIED. 4. IF THE COMPLAINED METERS OR STRIPS RETURNED FROM THE USER THROUGH THE IMPORTER, WE, APEX BIOTECHLOGOY CORP. (THE MANUFACTURER) WILL EVALUATE THE PRODUCT AND FILE A FOLLOW-UP MDR.

    Description of Event or Problem · 0

    COMPLAINED DEVICE SERIAL NUMBER: (B)(6) . CUSTOMER WAS UNABLE TO READ TEST STRIP INFORMATION. CUSTOMER CALLED STATING SHE NEEDS TO REPLACE HER METER DUE TO HER READINGS BEING HIGH AND ENDING UP IN THE EMERGENCY ROOM. THE PATIENT DESCRIBED WAKING UP AROUND 5 AM ON (B)(6) 2024, AND FEELING UNWELL AND EXPERIENCING INCREASED SWEATING AND WARMTH. SHE STATED FOR BREAKFAST SHE HAD TWO EGGS AND AN ORANGE AND DID NOT EAT ANYTHING FROM 12 - 8 PM. SHE GAVE HERSELF 80 UNITS OF LANTUS AT NOON. THROUGHOUT THE DAY, SHE MONITORED HER BLOOD SUGAR LEVELS, NOTICING THEY REMAINED ELEVATED. SHE STATED HER READINGS NORMALLY RANGE FROM 63 - 189. HER READING CAUSED CONCERN WHEN SHE STATED IT WAS READING AROUND 285 - 300 STILL LATE IN THE AFTERNOON. AT 8:35PM, SHE STATED SHE PERFORMED A BLOOD TEST WITH A READING OF 263, SHE WAITED FOR IT DECREASE BUT STATED IT DID NOT. THIS IS WHEN SHE ASKED HER SON TO TAKE HER TO THE ER FOR FURTHER EVALUATION. SHE STATED HER BLOOD GLUCOSE WAS RE-TESTED AND FOUND TO BE 140. MEDICAL STAFF OPTED FOR MONITORING RATHER THAN INTERVENTION, AND THEY STATED TO HER THIS IS A NORMAL READING, AND THE METER COULD POTENTIALLY DEFECTIVE AND ADVISED TO REPLACE METER. REPLACED METER, STRIPS, CONTROL SOLUTION AND SENT RETURN LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754701 GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM GLUCOCARD EXPRESSION NBW APEX BIOTECHNOLOGY CORP. 571100 00015482570101

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Life Threatening| R| H