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

Model Number STRIP, TMX AID 100CT12/CASE MG/DL

Device Problem Output Problem (3005)

Patient Problem Urinary Frequency (2275)

Event Date 03/16/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Meter and test strips were not returned for evaluation.Adverse event report is being submitted due to symptoms related to diabetes: urinary frequency.Note: manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved and that the replacement products resolved the initial concern - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint that the true metrix meter would powers up but would not go to test mode.Wife is calling on behalf of the customer.The product is not stored according to specification (bathroom).The customer did have another vial of test strips, mx4411s, but it was also stored in the bathroom.At the time of the call the customer reported having frequent urination and believed his blood glucose to be high.Medical attention was not needed at the time.

Manufacturer Narrative

Sections with additional information as of 20-may-2021: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: 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 strip lot tested and passed within specifications.Added most likely underline root cause mlc-020: user's test strip had poor storage.

• 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
• MDR Report Key: 11653584
• MDR Text Key: 245890975
• Report Number: 1000113657-2021-00249
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836
• Combination Product (y/n): N
• PMA/PMN Number: K140100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2022
• Device Model Number: STRIP, TMX AID 100CT12/CASE MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MX4374S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/16/2021
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other