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	02/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information provided by importer (arkray factory usa, inc.): complained products were not returned for evaluation.Retain strips of specificed lot were tested with reference meter and passed testing with no failures detected.If either meter or strips is returned, arkray (the importer) will evaluate the product and file a follow-up report.Manufacturer narrative: 1.In-house clinical capillary blood test (finger tip blood test), venous blood test and control solution test for retain meter and the same lot of retain strips are conducted.The results are passed with specified specifications.Please refer to the attachment "22000072-s8 finger tip test result", attachment "22000072-s8 venous blood test result" and attachment "22000072-s8 control solution test result" for details.2.Root cause or possible reason for this complaint has not been identified.3.If the complained meter or strips returned from the user through the importer, we, apex biotechnology corp.(the manufacturer) will evaluate the product and file a follow-up report.
Event or Problem Description
The caller indicated the glucocard expression meter was reading high.The caller performed a control solution test with a result of 117, with a range of 97-117.Then the caller found this control solution to be for a relion premier meter (cstn04cn), which is the incorrect control solution for glucocard expression meter.The caller performed back-to-back blood tests with results of 108 and 110.Importer explained 20% variance.The customer stated that last night at 3:30 am they were feeling bad.Customer stated they were feeling disoriented and tested their blood sugar with a result of 75.The customer called the paramedics who arrived and tested their blood giving them a reading of 35.The paramedics advised that they eat food to increase their blood sugar, so they ate a peanut butter sandwich and drank a soda.The customer told importer that the reason they called the paramedics was directly due to the readings of the meter.Importer explained that they would send a replacement meter and test strips and they would arrive in 3-5 business days with a return label to send back the complaint products.
Additional Manufacturer Narrative
Information provided by importer (arkray factory usa, inc.) (updated): on 02 dec 2022, meter and eleven strips of specified lot were returned for investigation.Returned strips were tested along with retain strips with returned meter.Meter and strips passed testing with no failures detected.Meter will be returned to the manufacturer for further investigation.Manufacturer narrative (updated): 1.The complained meter and empty test strip bottle of specified lot were received on 19 dec 2022.2.Investigation results of the returned meter, including functional test, are normal.Please refer to attachment 1 for details.3.In-house clinical capillary blood test (finger tip blood test) for the returned meter with specified lot of retain test strips is conducted.The results are passed within the specification.Please refer to attachment 3 for details.(amendment for the "22000072-s8 finger tip result" of the first emdr submission on 13 dec 2022: to remove information not related.Please see attachment 2.) 4.Additional moisture test to the desiccant in returned test strip bottle is performed and the result is acceptable.Please refer to attachment 4 for details.5.Root cause or possible reason for this complaint has not been identified.
Event or Problem Description
The caller indicated the glucocard expression meter was reading high.The caller performed a control solution test with a result of 117, with a range of 97-117.Then the caller found this control solution to be for a relion premier meter (cstn04cn), which is the incorrect control solution for glucocard expression meter.The caller performed back-to-back blood tests with results of 108 and 110.Importer explained 20% variance.The customer stated that last night at 3:30 am they were feeling bad.Customer stated they were feeling disoriented and tested their blood sugar with a result of 75.The customer called the paramedics who arrived and tested their blood giving them a reading of 35.The paramedics advised that they eat food to increase their blood sugar, so they ate a peanut butter sandwich and drank a soda.The customer told importer that the reason they called the paramedics was directly due to the readings of the meter.Importer explained that they would send a replacement meter and test strips and they would arrive in 3-5 business days with a return label to send back the complaint products.

• Brand Name: GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: GLUCOCARD EXPRESSION
• Manufacturer (Section D): APEX BIOTECHNOLOGY CORP.; no.7 li-hsin road v; hsinchu science park; hsinchu, taiwan 30078 ; TW 30078
• Manufacturer (Section G): APEX BIOTECHNOLOGY CORP.; no.7 li-hsin road v; hsinchu science park; hsinchu, taiwan 30078 ; TW 30078
• Manufacturer Contact: lisa liu ; no.7 li-hsin road v; hsinchu science park; hsinchu, taiwan 30078 ; TW 30078
• MDR Report Key: 15967562
• Report Number: 9616936-2022-00001
• Device Sequence Number: 20110569
• Product Code: NBW
• UDI-Device Identifier: 00015482570057
• UDI-Public: (01)00015482570101,(01)00015482570057
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 12/10/2022

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: 10/25/2023
• Device Model Number: 571100
• Device Catalogue Number: 571100
• Device Lot Number: B4S2201018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 96 KG