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	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for erratic blood glucose test results.Son is calling on behalf of the customer.The customer called concerned with test results from back-to-back test results of 93 and 203 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 blood test was performed by the customer fasting and produced test result of 164 mg/dl using trueness meter, per customer, the product is stored according to specification in the bedroom, the test strip lot manufacturer's expiration date is 06/22/2026 and per the customer the open vial date is (b)(6) 2025.The meter memory was reviewed for previous test result history: result 1: 231 mg/dl date: (b)(6) 2026 time: 11:49am fasting (ate 2 hr.Prior) result 2: 277 mg/dl date: (b)(6) 2026 time: 11:47am fasting result 3: 289 mg/dl date: (b)(6) 2026 time: 11:46am fasting result 4: 231mg/dl date: (b)(6) 2026 time: 1:17pm non-fasting result 5: 311 mg/dl date: (b)(6) 2026 time: 1:16pm non-fasting result 6: 93 mg/dl date: (b)(6) 2026 time: 1:45pm non fasting result 7: 203 mg/dl date:(b)(6) 2026 time: 1:47pm non fasting.
Additional Manufacturer Narrative
Internal report reference number :(b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause:pending completion.Note:follow-up calls are pending completion.Sinocare(a foreign manufacturer, fei #3016863723) and trividia health,inc,(a us.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 unique complaint number.

• 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; changsha, hunan CN 41 0205; CH CN 410205
• Manufacturer Contact: jeremy chow ; no.265 guyuan road; hi- tech; changsha, hunan CN 41-0205 ; CH CN 410205
• MDR Report Key: 24289337
• Report Number: 3016863723-2026-00001
• Device Sequence Number: 13357498
• Product Code: NBW
• UDI-Device Identifier: 00021292015084
• UDI-Public: (01)00021292015084(17)260622(10)4R6094
• 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: Other,Consumer,Health Professional
• 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: 06/22/2026
• Device Model Number: STRIP,TNS 200CT 30/CS
• Device Lot Number: 4R6094
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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