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
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strips tested within specifications.Retention testing was also 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: mlc-006: passed open expiration date note: 1.Manufacturer made several attempts to contact customer to ensure the replacement products resolved the initial concern - unable to establish contact with customer.2.Sinocare (a foreign manufacturer, fei #(b)(4) and (b)(6).(a u.S.Company/importer, fei #(b)(4) have entered into a customer service agreement.(b)(6).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 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 09/2025.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.

• 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 ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 24447302
• Report Number: 1000113657-2026-00077
• Device Sequence Number: 10443728
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/25/2026
• Report Date (Section F): 02/07/2026

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
• Distributor Facility Aware Date: 01/29/2026
• Date Report to Manufacturer: 02/07/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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