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

Model Number KIT, TRUE METRIX METERMG/DL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Presyncope (4410)

Event Date 06/08/2023

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).B2: adverse event report is being submitted due to symptoms related to diabetes: lightheaded.Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-069: using incorrect test strip.Note: manufacturer contacted customer in several follow-up calls to ensure the customer's condition had imrpoved - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint that she is unable to get the blood drop on the meter to do her test.Customer is using the incorrect test strips for the meter (different brand test strip).The customer reported feeling lightheaded and out of it; medical attention was not needed at the time of the call.Customer was going to purchase the correct test strips.

• 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: 17241969
• MDR Text Key: 318342297
• Report Number: 1000113657-2023-00357
• Device Sequence Number: 1
• Product Code: NBW
• 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
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: KIT, TRUE METRIX METERMG/DL
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/08/2023
• Date Manufacturer Received: 06/08/2023
• 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