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

Model Number	METER, PRO MCKESSON TMXMG/DL
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	Muscle Weakness/Atrophy (1967)
Date of Event	07/16/2025
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.Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-009: use error caused or contributed to event.Note: manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved and the replacement products resolved the initial concern- unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for dead meter.Customer stated that she had dropped the meter in water and that it is not working.Customer is using true metrix pro meter which is for multiple patient use.The customer reported feeling weak; medical attention was not needed at the time of the call.The customer stated she has not tested in 3 months "because she couldn't use the meter." test strip lot information was not provided; customer was unable to locate the test strips.Customer was provided with replacement true metrix products.

• Brand Name: TRUE METRIX PRO
• 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: 22742534
• Report Number: 1000113657-2025-00260
• Device Sequence Number: 8506991
• Product Code: NBW
• UDI-Device Identifier: 10612479210254
• UDI-Public: (01)10612479210254
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2025

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 Model Number: METER, PRO MCKESSON TMXMG/DL
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/16/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 08/07/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown