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	08/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Meter and one remaining test strip of specified lot involved in incident was returned for evaluation.Meter was evaluated with returned strip and retain strips of specified lot and performed to specification.No failure detected.
Event or Problem Description
Customer's wife was calling to report that the meter was reading too high.Reading is too high based on symptoms displayed and caller stated if the reading was accurate, customer wouldn't have been displaying symptoms.Patient was eating lunch and took insulin on his pump.Then he called to his wife and asked for help as he was experiencing severe hypoglycemic symptoms and having a hard time talking.He was then checked on the expression meter and the reading was 50.He was then checked on his bayer meter and the reading was 31.He was given juice and glucose gel after 15 minutes he was still very low, and the paramedics were called.He was given more glucose gel from them and it took two hours to get his blood sugar up.He was not taken to the hospital.Replaced meter, strips, sent cs and rl.
Additional Manufacturer Narrative
Section d10 from previous report was incorrect.This is a correction follow-up to update that information.
Event or Problem Description
Customer's wife was calling to report that the meter was reading too high.Reading is too high based on symptoms displayed and caller stated if the reading was accurate, customer wouldn't have been displaying symptoms.Patient was eating lunch and took insulin on his pump.Then he called to his wife and asked for help as he was experiencing severe hypoglycemic symptoms and having a hard time talking.He was then checked on the expression meter and the reading was 50.He was then checked on his bayer meter and the reading was 31.He was given juice and glucose gel after 15 minutes he was still very low, and the paramedics were called.He was given more glucose gel from them and it took two hours to get his blood sugar up.He was not taken to the hospital.Replaced meter, strips, sent cs and rl.

• 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: 10465269
• Report Number: 1832816-2020-00018
• Device Sequence Number: 16917123
• Product Code: NBW
• UDI-Device Identifier: 00015482570057
• UDI-Public: (01)00015482570101,(01)00015482570057
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2020
• Report Date (Section F): 08/28/2020

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: 08/19/2021
• Device Model Number: 571100
• Device Catalogue Number: 571100
• Device Lot Number: B4S1911009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/04/2020
• Device Age: 9 MO
• Event Location: Home
• Date Report to Manufacturer: 08/28/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 09/01/2020
• 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 Age: 70 YR
• Patient Weight: 84
• Date Report Sent to FDA: 08/28/2020