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

Model Number STRIP, LEADER TMX 50CTMG/DL

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2022

Event Type  malfunction  

Event Description

Consumer reported complaint for broken safety seal.Customer stated the safety seal on the vial of true metrix test strips had been broken when purchased; test strip lot manufacturer¿s expiration date is 03/29/2023.Customer stated the box was not open when received.Customer stated that she had tested using with the test strips and had obtained error messages; customer thought the error messages had been e-3.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.

Manufacturer Narrative

Internal report reference number: (b)(4).Test strips were not returned for evaluation.Complaint was forwarded to packaging and internal evaluation was completed.Packaging records were reviewed and no abnormalities were observed.Most likely underlying root cause: mlc-028: there was not enough information to determine the mlurc.Note: manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.

Manufacturer Narrative

Sections with additional information as of 20-oct-2022: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.Meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strips tested within specifications.Most likely underlying root cause: mlc-028: there was not enough information to determine the mlurc.

• Brand Name: TRUE METRIX
• Type of Device: 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: 15477164
• MDR Text Key: 306089237
• Report Number: 1000113657-2022-00511
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/29/2023
• Device Model Number: STRIP, LEADER TMX 50CTMG/DL
• Device Lot Number: ZY4480S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/29/2022
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1