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

Model Number	STRIP, TRUE METRIX 25CTMG/DL
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).B2: adverse event report is being submitted due to customer contacting doctor due to meter results.Meter was returned - reported defect not reproduced on returned meter.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: mlc-001: user had an inaccurate reference.Note: manufacturer contacted customer in a follow-up call on 15-nov-2023 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from result obtained of 861 mg/dl; customer could not recall the date he obtained the result and result could not be confirmed in meter memory.The customer does not know his expected blood glucose test result range.The customer feels well and did not report any symptoms.Customer stated that due to the high results he had contacted the nurse on (b)(3) 2023 and went to see the doctor the following day.Customer did not receive any medical treatment and customer was advised to replace meter.During the call, a back to back blood test was not performed by the customer.The test strip lot manufacturer¿s expiration date is 07/31/2024; storage and open vial date were not disclosed.After reviewing the results with customer, customer was not concerned with any of the results in the meter and agreed the result he thought he saw did not exist in the meter.The meter memory was reviewed for previous test result history: result 1: 110 mg/dl, date: (b)(3) 2023, time: 6:32am, fasting; result 2: 114 mg/dl, date: (b)(3) 2023, time: 6:18am, fasting; result 3: 82 mg/dl, date: (b)(3) 2023, time: 6:03am, fasting; result 4: 63mg/dl, date: (b)(3) 2023, time: 3:54pm, fasting; result 5: 169 mg/dl, date: (b)(3) 2023, time:n/a, non-fasting pm.

• Brand Name: TRUE METRIX
• 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: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 18231111
• Report Number: 1000113657-2023-00573
• Device Sequence Number: 6202616
• Product Code: NBW
• UDI-Device Identifier: 00021292007829
• UDI-Public: (01)00021292007829
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140100
• 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): 11/29/2023

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: 07/31/2024
• Device Model Number: STRIP, TRUE METRIX 25CTMG/DL
• Device Lot Number: ZA5118S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Distributor Facility Aware Date: 11/03/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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