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

Model Number	STRIP, TNS 50CT
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for high blood glucose test results.Wife is calling on behalf of the customer.The customer is concerned with test results from results obtained of 162 mg/dl.The customers' expected am fasting blood glucose test result range is 110-130 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.The product is not stored according to specification (kitchen).The test strip lot manufacturer's expiration date is (b)(6) 2026 and open vial date was not provided.The customer did not have another vial of test strips that had been stored and handled correctly.The meter memory was reviewed for previous test result history: result 1: 112 mg/dl date: (b)(6) 2025 time: 7:44am fasting am result 2: 132 mg/dl date: (b)(6) 2025 time: 8:33am fasting am result 3: 104 mg/dl date: (b)(6) 2025 time: 7:19am fasting am result 4: 132 mg/dl date: (b)(6) 2025 time: 8:16am fasting am result 5: 138 mg/dl date: (b)(6) 2025 time: 9:32am fasting am.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter was not returned for evaluation.Test strips were returned for evaluation.Product testing was performed and defect found on returned test strips: high blood readings.Importer's (thi) retention testing was performed using test strips from the same lot.Retention strips tested within specifications.Retention testing was performed by the manufacturer (sinocare inc.) using test strips from the same lot.Sinocare retention strip lot tested within specification.Root cause: (b)(4): storage outside specifications.Notes: 1.Manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.Note 2.In multiple fields the form indicates that manufacturer received product, however, (b)(4) received the product returned and conducted the product evaluation.Note 3.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 ((b)(4) - class 2) and records customer information, establishing a 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 CN410 205; CH CN410205
• Manufacturer Contact: jeremy chow ; no.265 guyuan road; hi-tech; changsha, hunan CN410-205 ; CH CN410205
• MDR Report Key: 23675559
• Report Number: 3016863723-2025-00012
• Device Sequence Number: 15914288
• Product Code: NBW
• UDI-Device Identifier: 00021292015084
• UDI-Public: (01)00021292015084(17)260627(10)4R6145
• 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: 06/27/2026
• Device Model Number: STRIP, TNS 50CT
• Device Lot Number: 4R6145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 11/28/2025
• 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