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

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
Investigation from importer (arkray usa inc,, hereafter : arkray).Arkray notified the manufacturer (apex biotechnology corp., hereafter: apexbio) on 25 aug 2020 that they have received a customer complaint which was a mdr.Arkray received the complained meter and test strip (1 piece) and performed tests.Results were pass.Investigation from manufacturer (apexbio): apexbio performed functional test to the returned meter.All tests were pass.Apexbio performed venous blood test and control solution test for returned meter and retain strips of complained lot of test strip.Results were pass.Apexbio performed additional moisture test to the desiccant in strip bottle.Results were acceptable.
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 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.

• Brand Name: GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM
• Manufacturer (Section D): APEX BIOTECHNOLOGY CORP.; no.7 li-hsin road v; hsinchu science park; hsinchu, taiwan 30078 ; TW 30078
• MDR Report Key: 10564824
• Report Number: 9616936-2020-00002
• Device Sequence Number: 2618292
• 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
• 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): 08/04/2020

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/21/2020
• 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