MAUDE Adverse Event Report: APEX BIOTECHNOLOGY CORP. GLUCOCARD EXPRESSION BLOOD GLUCOSE SYSTEM

Model Number	571100
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	04/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: GLUCOCARD EXPRESSION BLOOD GLUCOSE SYSTEM
• Common Device Name: GLUCOCARD EXPRESSION BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): APEX BIOTECHNOLOGY CORP.; no.7 li-hsin road v; hsinchu science park; hsinchu, taiwan 30078 ; TW 30078
• Manufacturer (Section G): APEX BIOTECHNOLOGY CORP.; no.7 li-hsin road v; hsinchu science park; hsinchu, taiwan 30078 ; TW 30078
• Manufacturer Contact: lisa liu ; no.7 li-hsin road v; hsinchu science park; hsinchu, taiwan 30078 ; TW 30078
• MDR Report Key: 17159984
• Report Number: 9616936-2023-00001
• Device Sequence Number: 12201910
• 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
• PMA/510(K) Number: K113098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Female