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 Failure to Power Up (1476)

Patient Problems Low Blood Pressure/ Hypotension (1914); Muscle Weakness (1967)

Event Date 06/01/2022

Event Type  Injury  

Event Description

Consumer reported complaint for dead meter.Wife is calling on behalf of the customer.Customer has been using the true metrix meter since 2021 and the battery has never been changed.The customer is using the correct battery in the correct orientation for the meter.During the call the true metrix meter powered on using the power button and when the test strip was inserted.The customer was not available to perform a blood test during the call.The customer feels well and did not report any symptoms.Wife stated that the day prior to the call she had brought the customer to the er.Customer had been feeling weak at the time and was unable to obtain a result on the meter due to it not powering on; wife stated she had brought customer to the hospital as she thought it was his blood glucose level.Customer was diagnosed with borderline diabetes and low blood pressure.Customer did not receive any treatment for diabetes.Customer was discharged the same day.

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) 2022 to ensure that the initial concern was resolved - able to establish contact with customer who stated is comfortable with the glucose readings from the product.

Manufacturer Narrative

Sections with additional information as of 05-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-062: user had poor technique.

• 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: 14830518
• MDR Text Key: 295036677
• Report Number: 1000113657-2022-00361
• 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: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/22/2022
• Device Model Number: KIT, TRUE METRIX METERMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZX4249S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/02/2022
• 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): Hospitalization