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

Model Number	STRIP, TMX TVH 30CT24/CASE MG/DL
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for missing safety seal and error message (e-3).Customer stated that the box had been sealed when received but that the test strip vial had not been sealed.The test strip lot manufacturer¿s expiration date is 03/20/2026 and test strips had been opened on the day of the call.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Customer had returned the incorrect meter, test strips, control solution, lancing device and lancets.Retention testing was performed using test strips from the same lot.Retention strip lot passed within specifications.Complaint was forwarded to packaging and internal evaluation completed.Packaging records were reviewed, no abnormalities observed.Most likely underlying root cause: mlc-009: use error caused or contributed to event.Note: manufacturer contacted customer in a follow-up call on 25-nov-2024 to ensure the replacement products resolved the initial concern - able to establish contact with customer who indicated replacement products resolved initial concern.

• 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: 20881331
• Report Number: 1000113657-2024-00486
• Device Sequence Number: 18118421
• Product Code: NBW
• UDI-Device Identifier: 00021292009472
• UDI-Public: (01)00021292009472(17)260320(10)ZC5817S
• 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): 12/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/20/2026
• Device Model Number: STRIP, TMX TVH 30CT24/CASE MG/DL
• Device Lot Number: ZC5817S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/14/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 12/09/2024
• 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
• Patient Sex: Unknown