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

Model Number STRIP, TMX HMN 50CT24/CASE MG/DL

Device Problem Image Display Error/Artifact (1304)

Patient Problem Dry Mouth (4485)

Event Date 10/25/2022

Event Type  Injury  

Event Description

Consumer reported complaint for error message (e-3).At the time of the call the customer reported he was experiencing "cotton mouth"; medical attention was not needed at the time.During the call, a blood test was performed by the customer fasting and produced test result of 200 mg/dl using true metrix meter; customer was satisfied with the result obtained.The product is stored according to specification in the living room.The test strip lot manufacturer¿s expiration date is 03/16/2024 and test strips were opened a few days prior to call.

Manufacturer Narrative

Internal report reference number: (b)(4).Outcomes attributed to adverse event: adverse event report is being submitted due to symptoms related to diabetes: dry mouth ("cotton mouth").Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-030: user applied blood to strip before inserting strip into meter.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.

Manufacturer Narrative

Sections with additional information as of 05-dec-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 tested within specifications.

• 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: 15824446
• MDR Text Key: 303902130
• Report Number: 1000113657-2022-00603
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/16/2024
• Device Model Number: STRIP, TMX HMN 50CT24/CASE MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZA4899S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/25/2022
• Date Manufacturer Received: 11/22/2022
• 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): Other