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 Insufficient Information (3190)

Patient Problem Numbness (2415)

Event Date 05/31/2022

Event Type  Injury  

Event Description

Consumer reported unknown complaint; customer stated that the true metrix meter was not working but was unable to describe the exact issue.The customer reported feeling tingling all over; medical attention was not needed at the time.The customer declined to perform a blood test during the call and stated she would contact manufacturer at a later time.The test strip lot manufacturer¿s expiration date is 09/13/2023; product storage and open vial date were not disclosed.The meter memory was not reviewed for previous test result history.

Manufacturer Narrative

(b)(4).Adverse event report is being submitted due to symptoms related to diabetes: tingling.Meter and test strips were not returned for evaluation.Customer did not provide telephone number, manufacturer was unable to contact the customer in follow-up calls to ensure the customer's condition had improved.

Manufacturer Narrative

Sections with additional information as of 08-aug-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.Most likely underlying root cause: mlc-028: there was not enough information to determine the mlurc.

• 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: 14794965
• MDR Text Key: 295025939
• Report Number: 1000113657-2022-00359
• 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: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/13/2023
• Device Model Number: STRIP, TMX HMN 50CT24/CASE MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZY4680S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/31/2022
• Date Manufacturer Received: 07/14/2022
• 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