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	07/13/2020
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 4 aug 2020 that they have received a customer complaint which was a mdr.Arkray received the complained meter and test strip (1 piece) on 21 aug 2020 and performed tests.Results were pass.Investigation from manufacturer (apexbio): apexbio performed venous blood test and control solution test for retain strips of complained lot of test strip after receiving arkray's notification.Results were pass.Apexbio received returned meter on 2 sep 2020 and performed functional test, venous blood test and control solution test for the returned meter with specific lot of retain strips.Results were pass.Apexbio performed additional moisture test to the desiccant in strip bottle.Results were acceptable.
Event or Problem Description
Caller got ready for day, and then she started shaking, and having hypoglycemia symptoms, so she checked her blood glucose and received a reading of 145.She did a control solution test that was in range.She called her granddaughter and called 911 and the ems came about 15 minutes later.They checked her blood glucose and it was 97, so they treated her with a glucose iv and within two minutes she stopped shaking.She then had her granddaughter take her to the hospital to get checked out.At the hospital, a few tests were performed, and they released her without any treatment of any sort.Caller also stated she has never felt like this before or experienced this before.

• 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: 10723951
• Report Number: 9616936-2020-00003
• Device Sequence Number: 11230759
• Product Code: NBW
• UDI-Device Identifier: 00015482570057
• UDI-Public: (01)00015482570101,(01)00015482570057
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 08/03/2020

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: 04/16/2021
• Device Model Number: 571100
• Device Catalogue Number: 571100
• Device Lot Number: B4S1907012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 10/23/2020
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 176