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

Model Number KIT, TRUE METRIX METERMG/DL

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number:(b)(4).Test strips were not returned for evaluation.Meter was returned.Reported defect not reproduced on returned meter.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.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2023 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

Event Description

Consumer reported complaint that the true metrix meter received had been previously used.Customer stated that the pharmacy gave him the meter as a promotional gift.Meter was opened yesterday.Customer advised that the meter was not in a box when he got it from the pharmacy, but it was in a carrying case.Customer stated that when he turned the meter on, there was a result already in the meter of 231 mg/dl.Customer stated that there was no evidence of blood anywhere on the meter and the vial of strips that he received was sealed and intact.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.

• 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: 18256303
• MDR Text Key: 329603986
• Report Number: 1000113657-2023-00582
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007690
• UDI-Public: (01)00021292007690
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140100
• 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
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/27/2024
• Device Model Number: KIT, TRUE METRIX METERMG/DL
• Device Lot Number: ZA4910S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Distributor Facility Aware Date: 11/08/2023
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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