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 Codes	Hypoglycemia (1912); Diaphoresis (2452)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information provided by importer (arkray factory usa, inc.): arkray attempted to gather strip lot information during initial call and request the return of subject meter and test strips.Actural products were not returned for testing and lot number is not known so retention samples could not be tested.If either strips or meter are returned, arkray will evaluate the product and file a follow-up report.Manufacturer narrative: 1.Complained meter was packed as a kit product which contained blood glucose test strip lot b4s2203013 and was delivered to arkray on may 2022.2.In-house clinical capillary blood test (finger tip blood test) for retain meter and retain sample of test strip lot b4s2203013 are conduced.The results are passed with specified specifications.Please refer to the attachment "24000014-s8 finger tip test result".3.Root cause or possible reason for this complaint has not been identified.4.If the complained meters or strips returned from the user through the importer, we, apex biotechlogoy corp.(the manufacturer) will evaluate the product and file a follow-up mdr.
Event or Problem Description
Complained device serial number: (b)(6).Customer was unable to read test strip information.Customer called stating she needs to replace her meter due to her readings being high and ending up in the emergency room.The patient described waking up around 5 am on (b)(6) 2024, and feeling unwell and experiencing increased sweating and warmth.She stated for breakfast she had two eggs and an orange and did not eat anything from 12 - 8 pm.She gave herself 80 units of lantus at noon.Throughout the day, she monitored her blood sugar levels, noticing they remained elevated.She stated her readings normally range from 63 - 189.Her reading caused concern when she stated it was reading around 285 - 300 still late in the afternoon.At 8:35pm, she stated she performed a blood test with a reading of 263, she waited for it decrease but stated it did not.This is when she asked her son to take her to the er for further evaluation.She stated her blood glucose was re-tested and found to be 140.Medical staff opted for monitoring rather than intervention, and they stated to her this is a normal reading, and the meter could potentially defective and advised to replace meter.Replaced meter, strips, control solution and sent return label.

• 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: 18910618
• Report Number: 9616936-2024-00001
• Device Sequence Number: 6886490
• Product Code: NBW
• UDI-Device Identifier: 00015482570101
• UDI-Public: (01)00015482570101
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/29/2024

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 Model Number: 571100
• Device Catalogue Number: 571100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2022
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 78 KG