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

Model Number	STRIP, TNS 50CT
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	Confusion/ Disorientation (2553)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for high blood glucose test results and high control test results.Daughter is calling on behalf of the customer.The customer is concerned with blood test results from results obtained of 194 and 177 mg/dl.Control test performed prior to the call produced result of 133 mg/dl.Control test not within acceptable range of 72-108 mg/dl.The customer¿s expected am fasting blood glucose test result range is 120-160 mg/dl.At the time of the call the customer felt well and did not report any symptoms.Daughter stated that earlier the customer had not been feeling well when the high blood glucose test results had been obtained; customer had been incoherent but had drank juice and then felt better.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The test strip lot manufacturer¿s expiration date is 09/03/2026 and open vial date was not provided.The product is not stored according to specification (kitchen).The customer did have another vial of test strips that had been stored and handled correctly: lot number 4r6156, manufacturer¿s expiration date is 06/28/2026 and opened on day of call.During the call, a blood test was performed by the customer non-fasting and produced test result of 140 mg/dl using trueness air meter.The meter memory was reviewed for previous test result history (date/time not set): result 1: 108mg/dl, date: (b)(6), time: 1:32a non-fasting, result 2: 194mg/dl , date: (b)(6), time: 12:41p non-fasting , result 3: 177mg/dl , date: (b)(6), time: 12:35p non-fasting, result 4: 80mg/dl , date: (b)(6), time: 12:20p unknown, result 5: 80mg/dl , date: (b)(6) time: 10:46p unknown.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).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-020: user's test strip had poor storage.Meter, test strips and control solution were returned and evaluation in-process.Notes: 1.Customer follow-ups calls were completed and unable to make contact.2.In multiple fields the form indicates that manufacturer received product, however trividia health, inc.(usa) received the products returned and will be conducting the product evaluation on the coming days.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.3.The manufacturer (sinocare) reported the mdr under mfr.Report number: 3016863723-2025-00001 on july 9, 2025.
Additional Manufacturer Narrative
Sections with additional information as of: 08-aug-2025 d9: device returned to manufacturer h3: device evaluated by manufacturer.H6: updated fda's type of investigation, investigation findings, and investigation conclusions h10: meter, test strips and 1 bottle of control solution were returned for evaluation (trividia health, inc.).Defect found on returned strips: high readings.Importer's (thi) retention testing was performed using test strips from the same lot.Retention strips tested within specifications.Reported defect not reproduced on returned meter.R&d tested the returned and retention strips with level- 1 control solution using the customer¿s meter.The two remaining returned strips produced high readings, while the retention sample results remained within the assigned range.Root cause: rc-072: vial left open for an extended period of time.

• Brand Name: TRUENESS AIR
• 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
• MDR Report Key: 22462303
• Report Number: 1000113657-2025-00234
• Device Sequence Number: 8560103
• Product Code: NBW
• UDI-Device Identifier: 00021292015084
• UDI-Public: (01)00021292015084(17)260903(10)4R8219
• 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,Followup
• Report Date (Section B): 08/08/2025
• Report Date (Section F): 06/20/2025

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: 09/03/2026
• Device Model Number: STRIP, TNS 50CT
• Device Lot Number: 4R8219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/13/2025
• Date Report to Manufacturer: 06/20/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/08/2025
• 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
• Patient Sex: Unknown