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

Model Number STRIP, CVS TMX 30CT24/CASE MG/DL

Device Problem Image Display Error/Artifact (1304)

Patient Problems Memory Loss/Impairment (1958); Speech Disorder (4415)

Event Date 05/10/2021

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Adverse event report is being submitted due to symptoms related to diabetes: slurred speech, forgetfulness.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 the initial concern was resolved - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for error message (e-3).Son is calling on behalf of the customer.The customer was not using the proper testing techniques.During the call, a blood test was performed by the customer fasting and produced test result of 317mg/dl using true metrix meter; customer was satisfied with the result obtained.The product storage location was not disclosed.The test strip lot manufacturer¿s expiration date is 07/31/2022 and open vial date is (b)(6) 2021.At the time of the call, the customer was experiencing symptoms of slurred speech and forgetfulness; medical attention was not needed at the time.

Manufacturer Narrative

Sections with additional information as of 12-jul-2021: 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 tested within specifications.Most likely underlying root cause: (b)(6): 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: 11942651
• MDR Text Key: 259462702
• Report Number: 1000113657-2021-00355
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292009120
• UDI-Public: (01)00021292009120
• 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: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2022
• Device Model Number: STRIP, CVS TMX 30CT24/CASE MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MX4433S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/10/2021
• Initial Date Manufacturer Received: 05/10/2021
• Initial Date FDA Received: 06/04/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other