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

Model Number	STRIP, TRUE METRIX 100CTMG/DL
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer reported complaint for low blood glucose test results.Caregiver is calling on behalf of the customer.The customer called concerned with test results from results obtained of 46, 47, 48, 77 mg/dl.The customer stated his expected blood glucose test result range is 111-119 mg/dl fasting am.The customer feels well and did not report any symptoms.Caregiver advise the customer got extremely low result (48mg/dl fasting am) on (b)(6) 2026.Caregiver gave the customer some honey and orange juice retest a 37 minutes later got a result of 47 mg/dl and as a result he called the paramedics which came out to the home at which time they tested the customer's blood sugar and got a result 113 mg/dl non-fasting and customer's meter tested at 83 mg/dl non-fasting.Caregiver advised he took the customer to the dr.For an issue not related to diabetes about a week and a half go (he could not recall the date of the dr visit) and stated he mentioned to the dr the meter is not working and was given a temporary meter to use until he could get in touch with the manufacturer.During the call, a back to back blood test was not performed by the customer.Per customer, the product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 07/16/2027 and per the customer the open vial date is 1 month ago.The meter memory was reviewed for previous test result history: result 1: 175mg/dl date: (b)(6) 2026, time: 4:47am fasting am, result 2: 46mg/dl date: (b)(6) 2026, time: 7:07am fasting am , result 3: 47mg/dl date: (b)(6) 2026, time: 6:17am non- fasting am , result 4: 48mg/dl date: (b)(6) 2026 , time: 5:54 fasting am , result 5: 77mg/dl date: (b)(6) 2026 , time: 8:19pm fasting am.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).B2: adverse event report is being submitted due to customer contacting paramedics due to meter results.Meter and test strips were returned - reported defect not reproduced on returned meter and strip.Retention testing was performed using test strips from the same lot.Retention strip lot passed within specifications.Most likely underlying root cause: mlc-134: user has low glucose value.Note: manufacturer contacted customer in a follow-up call on 01-apr-2026 to ensure the replacement products resolved the initial concern -able to establish contact with customer who stated they are comfortable with the glucose readings from the new replacement products.

• 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: juliana arias ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 24809722
• Report Number: 1000113657-2026-00163
• Device Sequence Number: 21499565
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836(17)270716(10)ZD6329S
• Combination Product (Y/N): N
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: STRIP, TRUE METRIX 100CTMG/DL
• Device Lot Number: ZD6329S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2026
• Distributor Facility Aware Date: 03/12/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/07/2026
• 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