MAUDE Adverse Event Report: SINOCARE INC TRUENESS AIR; SYSTEM,TEST,BLOOD GLUCOSE,0VER THE COUNTER

Model Number	STRIP,TNS 50CT
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Importer's (thi) retention testing and most likely underlying root cause pending completion.Notes: 1.Follow-up calls pending completion 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 truenesstm blood glucose monitoring system and truenesstm 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 control result out of control range and erratic blood glucose test results.The customer called concerned with test results from results obtained of 123, 146, 110 and 160 mg/dl.The customer stated his expected am fasting blood glucose test result is 120 mg/dl.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.Per customer, the product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 05/20/2027 and per the customer the open vial date is 2 weeks ago.The meter memory was reviewed for previous test result history (only 4 results provided) result: 1: 123 mg/dl date: (b)(6) 2026 time: 5:38 pm non-fasting result 2: 146 mg/dl date: (b)(6) 2026 time: 5:27 pm non-fasting result 3: 110 mg/dl date: (b)(6) 2026 time: 9:25 pm non-fasting result 4: 160 mg/dl date: (b)(6) 2026 time: 9:23 pm non-fasting.

• Brand Name: TRUENESS AIR
• Common Device Name: SYSTEM,TEST,BLOOD GLUCOSE,0VER THE COUNTER
• Manufacturer (Section D): SINOCARE INC; no,265 guyuan road; hi-tech zone; changsha, hunan CN410 205; CH CN410205
• Manufacturer (Section G): SINOCARE INC; no.265 guyaun road; hi-tech; changsha, hunan CN 41 0205; CH CN 410205
• Manufacturer Contact: jeremy chow ; no.265 guyaun road; hi-tech; changsha, hunan CN 41-0205 ; CH CN 410205
• MDR Report Key: 24452047
• Report Number: 3016863723-2026-00002
• Device Sequence Number: 13253931
• Product Code: NBW
• UDI-Device Identifier: 00021292015084
• UDI-Public: (01)00021292015084(17)270520(10)5R5072
• 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): Unknown
• 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 Model Number: STRIP,TNS 50CT
• Device Lot Number: 5R5072
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 02/26/2026
• 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