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

Model Number	571100
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	11/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
The caller indicated the glucocard expression meter was reading high.We performed a control solution test with a result of 117, with a range of 97-117.Found this control solution to be for a relion premier meter (cstn04cn), which is the incorrect control solution for this product.We performed back-to-back blood tests with results of 108 and 110.I explained 20% variance.The customer stated that last night at 3:30 am they were feeling bad.Customer stated they were feeling disoriented and tested their blood sugar with a result of 75.The customer called the paramedics who arrived and tested their blood giving them a reading of 35.The paramedics advised that they eat food to increase their blood sugar, so they ate a peanut butter sandwich and drank a soda.The customer told me that the reason they called the paramedics was directly due to the readings of the meter.I explained that we would send a replacement meter and test strips and they would arrive in 3-5 business days with a return label to send back the complaint products.Replaced meter, strips and sent return label.
Event or Problem Description
The caller indicated the glucocard expression meter was reading high.We performed a control solution test with a result of 117, with a range of 97-117.Found this control solution to be for a relion premier meter (cstn04cn), which is the incorrect control solution for this product.We performed back-to-back blood tests with results of 108 and 110.I explained 20% variance.The customer stated that last night at 3:30 am they were feeling bad.Customer stated they were feeling disoriented and tested their blood sugar with a result of 75.The customer called the paramedics who arrived and tested their blood giving them a reading of 35.The paramedics advised that they eat food to increase their blood sugar, so they ate a peanut butter sandwich and drank a soda.The customer told me that the reason they called the paramedics was directly due to the readings of the meter.I explained that we would send a replacement meter and test strips and they would arrive in 3-5 business days with a return label to send back the complaint products.Replaced meter, strips and sent return label.
Additional Manufacturer Narrative
On 12/2/2022, meter and eleven strips of specified lot were returned for investigation.Returned strips were tested along with retain strips with returned meter.Meter and strips passed testing with no failures detected.Meter will be returned to the manufacturer for further investigation.

• Brand Name: GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): APEX BIOTECHNOLOGY CORP.; no. 7 ii-hsin road v; hsinchu science park; hsinchu, 30078 ; TW 30078
• MDR Report Key: 15923908
• Report Number: 1832816-2022-00027
• Device Sequence Number: 17840946
• Product Code: NBW
• UDI-Device Identifier: 00015482570057
• UDI-Public: (01)00015482570101,(01)00015482570057
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 12/02/2022
• Report Date (Section F): 12/12/2022

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: 10/25/2023
• Device Model Number: 571100
• Device Catalogue Number: 571100
• Device Lot Number: B4S2201018
• 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: 11/11/2022
• Event Location: Home
• Date Report to Manufacturer: 12/12/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 12/12/2022
• 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: Required Intervention; Life Threatening
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Date Report Sent to FDA: 12/12/2022