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
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#: 3016863723) and trividia health, inc.(a u.S.Company/importer, fei#: 1000113657) 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.
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: on (b)(6) 2025 time: 9:14am fasting am result 2: 123 mg/dl date: on (b)(6) 2025 time: 4:52pm fasting am result 3: 107 mg/dl date: on (b)(6) 2025 time: 9:22am fasting am result 4: 126 mg/dl date: on (b)(6) 2025 time: 8:26am fasting am result 5: 93 mg/dl date: on (b)(6) 2025 time: 8:07am fasting am.

• 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 (Section G): SINOCARE INC; no.265 guyuan road; hi-tech zone; changsha, hunan CN 41 0205; CH CN 410205
• Manufacturer Contact: jeremy chow ; no.265 guyuan road; hi-tech zone; changsha, hunan CN 41-0205 ; CH CN 410205
• MDR Report Key: 23335113
• Report Number: 3016863723-2025-00004
• Device Sequence Number: 10612533
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial

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: 09/03/2025
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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