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

Model Number STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL

Device Problem Failure to Power Up (1476)

Patient Problem No Code Available (3191)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2021 to find out customer's condition and to ensure the replacement products resolved the initial concern and was able to establish contact with customer who stated is the issue is resolved and no further assistance is required.

Event Description

Consumer reported complaint meter dead meter, does not turn on with strip inserted.Daughter is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of moaning and slobbering the night before and medical attention is reported as a result of symptoms and meter not turning on.The product storage location is undisclosed.During the call a blood test was performed by the customer and produced test results which was not disclosed using the meter.Customer stated the issue started since the battery was changed.The test strip open vial date is undisclosed.The meter memory was not reviewed for previous test result history.

• 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: 11325389
• MDR Text Key: 234935047
• Report Number: 1000113657-2021-00110
• 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: Replace
• Type of Report: Initial
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/25/2021
• Device Model Number: STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MW4076S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/19/2021
• Date Manufacturer Received: 01/19/2021
• 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): Required Intervention