BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOCARD EXPRESSION BLOOD GLUCOSE SYSTEM

    MDR report key: 17159984 · Received June 19, 2023

    Report

    Report Number
    9616936-2023-00001
    Event Type
    Injury
    Date Received
    June 19, 2023
    Date of Event
    April 27, 2023
    Report Date
    April 27, 2023
    Manufacturer
    APEX BIOTECHNOLOGY CORP.
    Product Code
    NBW
    UDI-DI
    00015482570057
    PMA / PMN Number
    K113098
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION PROVIDED BY IMPORTER (ARKRAY FACTORY USA, INC.): METER AND STRIPS INVOLVED IN INCIDENT WERE NOT RETURNED FOR INVESTIGATION. RETAIN STRIPS OF SPECIFIED LOT WERE TESTED WITH QS METER AND PASSED TESTING WITH NO FAILURES DETECTED. IF CUSTOMER RETURNS ANY COMPLAINT PRODUCTS, PRODUCTS WILL BE TESTED AND A FOLLOW-UP MDR WILL BE FILED. MANUFACTURER NARRATIVE: 1. IN-HOUSE CLINICAL CAPILLARY BLOOD TEST (FINGER TIP BLOOD TEST), VENOUS BLOOD TEST AND CONTROL SOLUTION TEST FOR RETAIN METER AND THE SAME LOT OF RETAIN STRIPS ARE CONDUCTED. THE RESULTS ARE PASSED WITH SPECIFIED SPECIFICATIONS. PLEASE REFER TO THE ATTACHMENT "23000023-S8 FINGER TIP TEST RESULT". 2. ROOT CAUSE OR POSSIBLE REASON FOR THIS COMPLAINT HAS NOT BEEN IDENTIFIED. 3. IF THE COMPLAINT METER OR STRIPS RETURNED FROM THE USER THROUGH THE IMPORTER, WE, APEX BIOTECHOLOGY CORP. (THE MANUFACTURER) WILL EVALUATE THE PRODUCT AND FILE A FOLLOW-UP MDR.

    Description of Event or Problem · 0

    FRIEND (B)(6) IS CALLING IN FOR CUSTOMER. (B)(6). CUSTOMER HAS HAD THE METER FOR APPROXIMATELY TWO YEARS SHE THINKS. LOT B4S2201010 - 20230-10-11 - 50CT. CUSTOMER IS RECEIVING HIGHER READINGS. YESTERDAY THE CUSTOMER CALLED HER FRIEND BECAUSE SHE WAS NOT FEELING WELL. FRIEND (B)(6) METER READ 64 AND ROSA'S METER READ 280 IN A COMPARISON TEST. (B)(6) HAS NOVA MAX PLUS METER.THE FOLLOWING IS FROM THE HISTORY OF THE TWO METERS. PLEASE NOTE THE DATE IS INCORRECT ON ROSA'S METER AND THE CALLER IS UNSURE IF THE TIME IS SET CORRECTLY: CUSTOMER'S METER - (B)(6) - 5:36 - 280 WAS THE READING RECEIVED AND CUSTOMER CALLED HER FRIEND TO LET HER KNOW SHE WAS NOT FEELING WELL. CALLER'S METER - (B)(6) - 64 WAS THE READING RECEIVED AFTER SHE GOT TO HER HOURSE AROUND THE SAME TIME. CALLER GAVE CUSTOMER JUICE AT THIS TIME. CALLER'S METER - (B)(6) - 1:22PM - 143. THE FOLLOWING READINGS ARE THE READINGS RECEIVED ON THE CUSTOMER'S METER THAT CUSTOMER IS CLAIMING ARE TOO HIGH BEFORE THE INSTANCE OF THE COMPARISON READINGS ABOVE: (B)(6) - 18:05 - 336, (B)(6) - 18:08 - 208, (B)(6) - 18:08 - 288, (B)(6) - 18:09 - 274. (B)(6) STATES THAT THE READINGS FROM (B)(6) WERE NOT DONE WITH THE SAME BLOOD SAMPLE, BUT MAY HAVE BEEN DONE ON DIFFERENT HANDS. RAQUEL IS GOING TO GO OVER AND CHECK ROSA'S BLOOD GLUCOSE WITH HERE METER EACH DAY UNTIL REPLACEMENT IS RECEIVED. REPLACED METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546328 GLUCOCARD EXPRESSION BLOOD GLUCOSE SYSTEM GLUCOCARD EXPRESSION BLOOD GLUCOSE SYSTEM NBW APEX BIOTECHNOLOGY CORP. 571100 B4S2201010 00015482570057

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| L