MAUDE Adverse Event Report: TRIVIDIA HEALTH INC TRUE FOCUS; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number	STRIP, TF WGN 50CTMG/DL 956970
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Codes	Fatigue (1849); Muscle Weakness/Atrophy (1967); Nausea (1970); Shaking/Tremors (2515)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).B2: adverse event report is being submitted due to symptoms related to diabetes: weak, tired, shaky and nauseous.Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-012: product expired.Note 1: manufacturer contacted customer in a follow-up call on 16-sep-2024 to ensure the customer's condition had improved and that the replacement products resolved the initial concern - able to establish contact with customer who stated her symptoms have not improved.Customer stated she is shaky and feeing nauseous.No medical intervention since the last call was reported.Customer stated that the replacement products did not resolve the initial concern: internal report reference number (b)(4).Note 2: manufacturer contacted customer in a follow-up calls to ensure the customer's condition had improved - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for lo blood glucose test results.The customer is concerned with test results from results obtained of lo.The customer stated that she has not used the true focus meter since may.The customer does not know her expected blood glucose test result range.The customer reported feeling weak and tired; medical attention was not needed at the time of the call.During the call, a back-to-back blood test was not performed by the customer.The product is stored according to specification in the bedroom.The customer's test strips are expired: test strip lot manufacturer¿s expiration date is (b)(6) 2023 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: lo date:(b)(6) 2024 time: 9:41 pm fasting/non-fasting unknown.Result 2: lo date:(b)(6) 2024 time: 9:39 am fasting/non-fasting unknown.Result 3: 145 mg/dl date (b)(6) 2024 time: 8:37 pm fasting/non-fasting unknown.Result 4: 132 mg/dl date: (b)(6) 2024 time: 8:04 pm fasting.Result 5: 150 mg/dl date: (b)(6) 2024 time: 7:13 pm fasting.

• Brand Name: TRUE FOCUS
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: juliana arias ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 20350331
• Report Number: 1000113657-2024-00397
• Device Sequence Number: 8024591
• Product Code: NBW
• UDI-Device Identifier: 00021292008956
• UDI-Public: (01)00021292008956(17)231019(10)NY1013
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other,Replace
• Type of Report: Initial
• Report Date (Section B): 10/02/2024

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: 10/19/2023
• Device Model Number: STRIP, TF WGN 50CTMG/DL 956970
• Device Lot Number: NY1013
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/09/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 10/02/2024
• 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