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	High Readings (2459)
Health Effect - Clinical Codes	Hypoglycemia (1912); Malaise (2359)
Date of Event	04/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Friend raquel is calling in for customer.Rj038296.Customer has had the meter for approximately two years she thinks.Lot b4s2201010 - 2023-10-11 - 50ct.Customer is receiving higher readings.Yesterday the customer called her friend because she was not feeling well.Friend raquel's meter read 64 and rosa's meter read 280 in a comparison test.Raquel 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 - 8/28 - 5:36 - 280 was the reading received and customer called her friend to let her know she was not feeling well.Caller's meter - 4/26 - 64 was the reading received after she got to her house around the same time.Caller gave customer juice at this time.Caller's meter - 4/26 - 1:22 pm - 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: 8/24 - 18:05 - 336, 8/24 - 18:08 - 208, 8/24 - 18:08 - 288, 8/24 - 18:09 - 274.Raquel states that the readings from 8/24 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 her meter each day until replacement is received.Replaced meter, strips and sent return label.
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.

• 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 ii-hsin road v; hsinchu science park; hsinchu, 30078 ; TW 30078
• MDR Report Key: 16974293
• Report Number: 1832816-2023-00009
• Device Sequence Number: 6442908
• Product Code: NBW
• UDI-Device Identifier: 00015482570057
• UDI-Public: (01)00015482570101,(01)00015482570057
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2023
• Report Date (Section F): 05/22/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/11/2023
• Device Model Number: 571100
• Device Catalogue Number: 571100
• Device Lot Number: B4S2201010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/27/2023
• Event Location: Home
• Date Report to Manufacturer: 05/22/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2023
• 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: Life Threatening; Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 05/22/2023