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

Model Number STRIP, WGN TMX 60CT 12/CASE MG/DL

Device Problem Image Display Error/Artifact (1304)

Patient Problems Anxiety (2328); Insufficient Information (4580)

Event Date 10/18/2022

Event Type  Injury  

Event Description

Consumer reported complaint for error message (e-2).The test strip lot manufacturer¿s expiration date is 01/31/2024 and open vial date is 10/12/2022.The product is not stored according to specification (kitchen).The customer did have another vial of test strips, same lot number, that had been stored and handled correctly.During the call, back to back blood tests were performed by the customer and produced e-5 and e-0 errors using true metrix meter.The customer feels well and did not report any symptoms.Customer stated that he had gone to the er on (b)(6) 2022 because he was not feeling well.Customer was not sure if was due to his diabetes or because he was feeling anxious, and because the meter was not reading his glucose.Customer stated that at the er his glucose was 170 mg/dl non fasting.Customer was released same day and was advised to follow up with his doctor.

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-020: user's test strip had poor storage.Note: manufacturer contacted customer in several follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.

Manufacturer Narrative

Sections with additional information as of 02-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: 15787863
• MDR Text Key: 303553900
• Report Number: 1000113657-2022-00589
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292009120
• UDI-Public: (01)00021292009120
• 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: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2024
• Device Model Number: STRIP, WGN TMX 60CT 12/CASE MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZA4873S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/18/2022
• Date Manufacturer Received: 11/15/2022
• 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