TRUENESS AIR
Report
- Report Number
- 3016863723-2025-00001
- Event Type
- Malfunction
- Date Received
- July 9, 2025
- Date of Event
- June 13, 2025
- Report Date
- July 9, 2025
- Manufacturer
- SINOCARE INC.
- Product Code
- NBW
- UDI-DI
- 000212901584
- PMA / PMN Number
- K231476
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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. REMARK: 1. THIS COMPLAINT EVENT OCCURRED IN THE UNITED STATES. THE CUSTOMER RETURNED THE ALLEGED PRODUCTS FOR INVESTIGATION. THE IMPORTER (THI) COMPLETED THE DEVICE EVALUATION SUCCESSFULLY WITHOUT REQUIRING ADDITIONAL INPUT FROM THE FOREIGN MANUFACTURER.THE IMPORTER SUBMITTED THE REPORT UNDER NUMBER: 1000113657-2025-00234. 2. THE DATE FORMAT FOR ENTERING INTO ESUBMITTER IS MM/DD/YYYY, WHEREAS THE DATE FORMAT IN THE 3500A FORM OUTPUT BY ESUBMITTERIS DD-MMM-YYYY. THIS DISCREPANCY HAS CAUSED THE DATES TO APPEAR MISSING IN THE OUTPUT 3500A FORM. THE ACTUAL DATES ARE AS FOLLOWS: D9: DATE OF THE GOODS RETURNED TO THE MANUFACTURER (DD-MMM-YYYY): 01-07-2025, G3: DATE RECEIVED BY MANUFACTURER (DD-MMM-YYYY): 10-07-2025, H4: DEVICE MANUFACTURE DATE (DDMMM-YYYY): 04-09-2024.
1. TABLE FILLING INSTRUCTIONS. 1.1 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. TO PROTECT PRIVACY AND COMPLY WITH ESUBMITTER FORMAT REQUIREMENTS, PARTS OF THE PATIENT INFORMATION (PART A) AND INITIAL REPORTER INFORMATION (PART E) IN THE REPORT USE INTERNAL IDENTIFIERS, SUCH AS (B)(6) (A1), AND (B)(6) (E1). THE ACTUAL INFORMATION IS TRACEABLE USING TRIVIDIA HEALTH, INC.'S INTERNAL NUMBER (CASE: (B)(4). 1.2 THE DATE FORMAT FOR ENTERING INTO ESUBMITTER IS MM/DD/YYYY, WHEREAS THE DATE FORMAT IN THE 3500A FORM OUTPUT BY ESUBMITTER IS DD-MMM-YYYY. THIS DISCREPANCY HAS CAUSED THE DATES TO APPEAR MISSING IN THE OUTPUT 3500A FORM. THE ACTUAL DATES ARE AS FOLLOWS: B3: DATE OF EVENT (DD-MMM-YYYY): 13-06-2025, B4: DATE OF EVENT (DD-MMM-YYYY): 09-07-2025, D4: EXPIRATION DATE (DD-MMM-YYYY):03-09-2026, G3: DATE RECEIVED BY MANUFACTURER (DD-MMM-YYYY): 13-06-2025, H4: DEVICE MANUFACTURE DATE (DD-MMM-YYYY): 04-09-2024. 1.3 DUE TO ESUBMITTER ONLY ALLOWS INPUT OF THE CONTINUOUS DIGITS 086073189935623, BUT AFTER EXPORTING FROM THE SOFTWARE, THE FORMAT IN THE 3500A TABLE BECOMES 086-073-189935623, WHILE THE ACTUAL CORRECT FORMAT SHOULD BE 086-0731-89935623. 2. INVESTIGATION FINDINGS: 2.1 RETENTION TESTING WAS PERFORMED BY THE MANUFACTURER (SINOCARE INC.) USING TEST STRIPS FROM THE SAME LOT: 4R8219. SINOCARE RETENTION STRIP LOT TESTED WITHIN SPECIFICATION. 3. MOST LIKELY UNDERLYING ROOT CAUSE. MLC-020: USER'S TEST STRIP HAD POOR STORAGE. NOTE: A. CUSTOMER CARE COMPLETED THE FOLLOW-UP CALLS AND WERE UNABLE TO MAKE CONTACT WITH CUSTOMER. B. THE RETURNED PRODUCTS INVESTIGATION CONDUCTED BY TRIVIDIA HEALTH, INC. (A U.S. COMPANY/IMPORTER) AND PENDING THE RESULTS.
CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD RESULTS AND 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 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 RESULTS 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 HAVE BEEN STORED 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-FASTION 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 1:108 MG/DL DATE: ON (B)(6) TIME: 1:32A NON-FASTING; RESULT 2: 194 MG/DL DATE: ON (B)(6) TIME:12:41P NON-FASTING; RESULT 3: 177 MG/DL DATE: ON (B)(6) TIME: 12:35P NON-FASTING; RESULT 4: 80 MG/DL DATE: ON (B)(6) TIME: 12:20P UNKNOWN; RESULT 5: 80 MG/DL DATE: ON (B)(6) TIME:10:46P UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149406 | TRUENESS AIR | SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER | NBW | SINOCARE INC. | STRIP,TNS 50CT | 4R8219 | 000212901584 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |