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	Image Display Error/Artifact (1304)
Health Effect - Clinical Codes	Headache (1880); Shaking/Tremors (2515)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer reported complaint for error message (e-7).The customer reported feeling shaky and having a headache.Medical attention was not needed at the time of the call.The product is stored according to specification in the living room.The test strip lot manufacturer¿s expiration date is 07/19/2026 and open vial date was not provided.Customer also advised he purchased 4 containers of test strips and mixed the containers together.Customer stated the error occurred before he mixed the test strips.Customer declined running a blood test during the call.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).B2: adverse event report is being submitted due to symptoms related to diabetes: headache and shakiness.Meter and test strips were not returned for evaluation.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.Most likely underlying root cause: mlc-014: insufficient blood sample applied to strip (user) notes: 1.Manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved and the replacement products resolved the initial concern - unable to establish contact with customer at this time.2.Sinocare (a foreign manufacturer, fei #3016863723) and trividia health, inc.(a u.S.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 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 Contact: juliana arias ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 23305353
• Report Number: 1000113657-2025-00372
• Device Sequence Number: 13243322
• Product Code: NBW
• UDI-Device Identifier: 00021292015084
• UDI-Public: (01)00021292015084(17)260719(10)4R7065
• 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): 10/15/2025
• Report Date (Section F): 10/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/19/2026
• Device Model Number: STRIP, TNS 200CT 30/CS
• Device Lot Number: 4R7065
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/18/2025
• Date Report to Manufacturer: 10/04/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 10/15/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown