MAUDE Adverse Event Report: APEX BIOTECHNOLOGY CORP. GLUCOCARD EXPRESSION BLOOD GLUCOSE SYSTEM; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number	571100
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer states she is receiving low readings on her two expression meters, and she went to the er as a result.Customer states her control solution was opened in (b)(6) 2024, but did a test and thought it was out of range with a reading of 105 and the range was 90-122.Advised customer that control solution is good for three months once opened.The customer is unsure how long she has had the meters.She states we sent her one of them and the other she purchased from her local store.Customer states she used both meters today and received readings of 62 at 8:31 am which concerned her and prompted her to go to the hospital around 8:49 am.She used two different samples on two different hands using a new lancet.When she went to the hospital, they tested her and received a reading of 105, and after eating food, the reading was 189.They discharged her after monitoring her glucose after eating food.When she arrived home, both of her expression meters gave her a result of 102, which she still feels is too low.Customer states she has had very controlled diabetes for years, but with the low readings on both meters and the way she was feeling, she went to the hospital.Customer stores meter and strips in her bedroom.Customer washes and dries hands before testing.Customer uses a new lancet.Replaced both meters and test strips for her.Explained the return process and mailed return label.
Additional Manufacturer Narrative
The meter and strips involved in the incident were not returned for investigation.The retain strips of the specified lot were tested with a qs meter and passed testing with no failures detected.If the customer returns any complaint products, the products will be tested and a follow-up mdr will be filed.
Additional Manufacturer Narrative
The meter and strips involved in the complaint were returned on 3/7/2025.The returned strips were used up for testing the customer's other complaint meter, el963517.The returned meter was tested with retain strips of the specified lot with both blood and retain control solution, lot tac230907m, expiration 2025-09-13.Blood and control solution passed testing with no failures detected.The meter will be forward to the manufacturer.

• Brand Name: GLUCOCARD EXPRESSION BLOOD GLUCOSE SYSTEM
• Common Device Name: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): APEX BIOTECHNOLOGY CORP.; no. 7 li-hsin 5th road; hsinchu science park; hsinchu 30078 ; TW 30078
• MDR Report Key: 21572137
• Report Number: 1832816-2025-00003
• Device Sequence Number: 8647628
• Product Code: NBW
• UDI-Device Identifier: 00015482570101
• UDI-Public: (01)00015482570101
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025
• Report Date (Section F): 04/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/09/2026
• Device Model Number: 571100
• Device Catalogue Number: 571100
• Device Lot Number: B4S2404006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/14/2025
• Event Location: Home
• Date Report to Manufacturer: 04/01/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Date Report Sent to FDA: 04/01/2025