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

Model Number	STRIP, TNS 200CT 30/CS
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were returned for evaluation: reported defect not reproduced on returned meter and strip.Importer's (thi) retention testing was performed using test strips from the same lot.Retention testing was performed by the manufacturer (sinocare inc.) using test strips from the same lot.Sinocare retention strip lot tested within specification most likely underlying root cause: (b)(4): user had an inaccurate reference: competitor¿s meter: the end user is comparing results obtained from (b)(4) to the results from a competitor¿s bgm system notes: 1.Customer follow-ups calls were completed and unable to make contact.2.*sinocare (a foreign manufacturer, fei # (b)(4)) and (b)(4) (a u.S.Company/importer, fei # (b)(4)) have entered into a customer service agreement.(b)(4) 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 lo blood glucose test results.The customer is concerned with test results from results obtained of lo.Customer stated she obtained the lo about 20-30 minutes after eating.Customer stated she performed a blood test using another device and obtained a result of 161 mg/dl non-fasting.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 dining room.The test strip lot manufacturer¿s expiration date is 01/02/2027 and open vial date is (b)(6) 2025.The meter memory was reviewed for previous test result history (date/time not set): result 1: lo date: (b)(6), time: 7:06pm, non-fasting.

• 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
• MDR Report Key: 23598254
• Report Number: 1000113657-2025-00422
• Device Sequence Number: 18464162
• Product Code: NBW
• UDI-Device Identifier: 00021292015084
• UDI-Public: (01)00021292015084(17)270102(10)4RC203
• 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
• Report Date (Section B): 11/19/2025
• Report Date (Section F): 10/31/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: STRIP, TNS 200CT 30/CS
• Device Lot Number: 4RC203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2025
• Distributor Facility Aware Date: 10/20/2025
• Date Report to Manufacturer: 10/31/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/19/2025
• 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