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

Model Number STRIP, TMX WGN 100CT12/CS MG/DL #383569

Device Problem Image Display Error/Artifact (1304)

Patient Problem Fatigue (1849)

Event Date 11/18/2022

Event Type  malfunction  

Event Description

Consumer reported complaint for error messages (e-2 and e-3).At the time of the call the customer reported feeling fatigued and customer stated she had contacted her doctor that morning.Doctor had advised customer to contact manufacturer and to continue to monitor her glucose.During the call, a blood test was performed by the customer non-fasting and produced test result of 144 mg/dl using true metrix meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 12/24/2023 and open vial date is two weeks ago.

Manufacturer Narrative

Internal report reference number: (b)(4).Adverse event report is being submitted due to customer contacting doctor due to symptoms related to diabetes: fatigue.Meter and test strips were not returned for evaluation.Added most likely underlying root cause onto case.No expected product returned; complaint was resolved by training.Most likely underlying root cause: mlc-062: user had poor technique.Note: manufacturer contacted customer in a follow-up call on 22-nov-2022 to ensure that the customer's condition had improved - able to establish contact with customer who stated her condition had improved and she did not currently have any diabetic symptoms.No additional medical intervention since the last call was reported.

Manufacturer Narrative

Sections with additional information as of 12-jan-2023: 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: 15970092
• MDR Text Key: 308239317
• Report Number: 1000113657-2022-00648
• 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: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/24/2023
• Device Model Number: STRIP, TMX WGN 100CT12/CS MG/DL #383569
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZA4814S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/18/2022
• Date Manufacturer Received: 12/20/2022
• 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