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

Model Number STRIP, TMX WGN 50CTMG/DL #348014

Device Problems Low Test Results (2458); Output Problem (3005)

Patient Problem Fainting (1847)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-78: user hematocrit low.Note: manufacturer contacted customer in multiple follow-up calls to find out customer's condition and to ensure that the initial concern was resolved - unable to establish contact with customer at this time.

Event Description

Costumer reported complaint for error messages e-0 and e-3.Wife is calling on behalf of the customer.The product is stored according to specification in the living room.The manufacturer's expiration date is 12/30/2021 and open vial date is (b)(6) 2020.During the call, a blood test was performed by the customer and produced e-0 using true metrix meter; another blood test was performed and result obtained was 28 mg/dl (undisclosed if fasting/non-fasting).Wife stated that she believed the customer's blood glucose is low.Wife stated that customer's eyes were rolling back; wife was instructed to call 911/customer's doctor.No further information was able to be obtained.

Manufacturer Narrative

Sections with additional information as of 06-dec-2020: h6: updated fda's method, result, and conclusion codes.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.Most likely underlying root cause updated from "mlc-78: user hematocrit low¿ to "mlc-062 user had poor technique".

• 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: 10722323
• MDR Text Key: 229185638
• Report Number: 1000113657-2020-00775
• Device Sequence Number: 1
• Product Code: NBW
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/30/2021
• Device Model Number: STRIP, TMX WGN 50CTMG/DL #348014
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MX4300S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/25/2020
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention