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

Model Number STRIP, TMX WGN 25CT24/CS MG/DL #383237

Device Problem Image Display Error/Artifact (1304)

Patient Problems Fever (1858); Headache (1880); Dizziness (2194); Numbness (2415)

Event Date 07/25/2022

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved and that the initial concern is resolved - unable to establish contact with customer at this time.

Event Description

Consumer called for assistance with performing a blood test.The customer stated he wanted to check his blood sugar as last night he had a fever and headache, and that morning he had felt dizzy and had numbness in his right side.Customer stated he was feeling better at the time of the call.The product is stored according to specification (location undisclosed).The test strip lot manufacturer¿s expiration date is 06/30/2023 and open vial date is 07/25/2022.During the call, blood tests were performed by the customer and produced error messages e-2, e-0 and e-2.Customer was having difficulty with getting a blood sample.Manufacturer was going to contact customer at a later time to attempt to perform another blood test.When contacted by manufacturer later the same day, customer reported he was currently seeking medical intervention.Customer stated he was feeling dizzy and was not able to obtain a blood glucose test result and so he had gone to the hospital.Customer was still at the hospital at the time of the call and stated that they were checking his blood glucose.Customer requested manufacturer contact him at a later date.No further information was able to be obtained.

Manufacturer Narrative

Sections with additional information as of 13-sep-2022: h6: updated fda¿s type, findings and conclusions 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 passed within specifications.Most likely underlying root cause: 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
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 15260353
• MDR Text Key: 298241075
• Report Number: 1000113657-2022-00453
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007829
• UDI-Public: (01)00021292007829
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Model Number: STRIP, TMX WGN 25CT24/CS MG/DL #383237
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZY4610S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/25/2022
• Date Manufacturer Received: 08/23/2022
• 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
• Patient Outcome(s): Hospitalization