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 Readings (2459)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	01/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint products were not returned for evaluation.Retain strips of specified lot were tested with reference meter and passed testing with no failures detected.If either meter or strips is returned, arkray will evaluate the product and file a follow-up report.
Event or Problem Description
Meter is less than two months old.Meter, test strips, and lancing device stored in the pouch in a drawer in his bedroom.Has been a diabetic awhile.At the time of this call, the meter's date and time were not accurate and were showing (b)(6) 2021, not (b)(6) 2021.Had been doing a side-by-side test with a continuance blood sugar testing system (libre) at the same time as using this meter per doctor's request.The libre was showing him along his lower rungs, while the expression meter at the same time was showing him high.He does have a recent a1c test result of 5.7 and previous ones of 5.5.He was taking additional readings during the week.Customer was noticing some fluctuations in the readings during the week.Around 8 pm on (b)(6) 2021 he received a reading of almost 400.He had not taken his long-term insulin yet.He normally takes that around 10-11 pm at night when he is going to bed.He took some additional short-term insulin, which he had initially taken at about 7 pm when he had dinner.In the early morning, he was still concerned so he took some additional readings which were in the 300-400 range.He took some more short-term insulin since it was not going down.Caller said he felt like he was going into shock so called for ems services.Told them on the phone he felt like he was going into shock.Said he could not get his blood sugar to go down according to the meter.Caller said by time ambulance got to his residence, he could not think and was feeble.He wanted to lay down and sleep.He does not remember what was said while he was on the ambulance.The blood sugar reading at the hospital was 17.They kept him overnight for observation and he was released late on (b)(6) 2021.He then came home and did a couple control solution tests.They were reading within range on the bottle of 100 and 101.Range for level 1 is 92-124.Replaced meter, 50ct strips, and sent return label.

• 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: 11274281
• Report Number: 1832816-2021-00001
• Device Sequence Number: 14414445
• Product Code: NBW
• UDI-Device Identifier: 00015482570057
• UDI-Public: (01)00015482570101,(01)00015482570057
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/09/2021
• Report Date (Section F): 02/03/2021

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: 01/21/2022
• Device Model Number: 571100
• Device Catalogue Number: 571100
• Device Lot Number: B4S2004001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/09/2021
• Device Age: 10 MO
• Event Location: Home
• Date Report to Manufacturer: 02/03/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2021
• 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: 58 YR
• Patient Weight: 120
• Date Report Sent to FDA: 02/03/2021