MAUDE Adverse Event Report: SINOCARE INC TRUENESS; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number	STRIP, TNS 50CT
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 122, 123, 107, 126 and 93 mg/dl.The customer does not know their expected blood glucose test result range.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call, a back-to-back blood test was not performed by the customer.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 09/03/2026 and open vial date is 2 weeks ago.The meter memory was reviewed for previous test result history (time not set): result 1: 122 mg/dl date: (b)(6) 2025 time: 9:14am fasting am.Result 2: 123 mg/dl date: (b)(6) 2025 time: 4:52pm fasting am.Result 3: 107 mg/dl date: (b)(6) 2025 time: 9:22am fasting am.Result 4: 126 mg/dl date: (b)(6) 2025 time: 8:26am fasting am.Result 5: 93 mg/dl date: (b)(6) 2025 time: 8:07am fasting am.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter, test strips and control solution were returned - product evaluation in-process.Retention testing was performed using test strips from the same lot.Retention strip lot passed within specifications.Most likely underlying root cause: mlc-058: user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Notes: 1.In multiple fields the form indicates that manufacturer received product, however trividia health, inc.(usa) received the products returned and will be conducting the product evaluation on the coming days.2.Sinocare (a foreign manufacturer, fei # (b)(4)) and trividia health, inc.(a u.S.Company/importer, fei # (b)(4) have entered into a customer service agreement.Trividia health, inc.Handles customer complaints for the trueness¿ blood glucose monitoring system and trueness¿ air blood glucose monitoring system (k231476 - class 2) and records customer information, establishing a unique complaint number.
Additional Manufacturer Narrative
Sections with additional information as of: 20-nov-2025 h3: device evaluated by manufacturer.H6: updated fda's type of investigation, investigation findings, and investigation conclusions h10: meter, test strips and 1 bottle of control solution were returned for evaluation (trividia health, inc.).Defect found on returned strips: high readings.Reported defect not reproduced on returned meter or control solution.R&d tested the returned and retention strips with level- 1 and 2 control solution using the customer¿s meter.The returned strips produced high readings, while the retention sample results remained within the assigned range.Sinocare retention strip lot tested within specification root cause: rc-061: storage outside specifications.

• Brand Name: TRUENESS
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): SINOCARE INC; no.265 guyuan road; hi-tech zone; changsha, hunan CN 41 0205; CH CN 410205
• Manufacturer Contact: juliana arias ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 23304008
• Report Number: 1000113657-2025-00371
• Device Sequence Number: 18637068
• Product Code: NBW
• UDI-Device Identifier: 00021292015084
• UDI-Public: (01)00021292015084(17)260903(10)4R8219
• Combination Product (Y/N): N
• PMA/510(K) Number: K231476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025
• Report Date (Section F): 10/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/03/2026
• Device Model Number: STRIP, TNS 50CT
• Device Lot Number: 4R8219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/18/2025
• Date Report to Manufacturer: 10/04/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown