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	07/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Meter and test strips involved in incident were returned for evaluation.Meter was evaluated with returned strips of specified lot and performed to specification.No failure detected.
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 cs 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.Replaced meter, strips, sent cs and return label.
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 cs 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.Replaced meter, strips, sent cs and return label.
Additional Manufacturer Narrative
Section d10 from previous report was incorrect.This is a correction follow-up to update that information.

• 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: 10465199
• Report Number: 1832816-2020-00017
• Device Sequence Number: 2390841
• 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): 08/03/2020
• 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: 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/03/2020
• Device Age: 1 YR
• 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: 08/31/2020
• 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
• Date Report Sent to FDA: 08/28/2020