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 Failure to Power Up (1476)

Patient Problems Diarrhea (1811); Vomiting (2144); Dizziness (2194)

Event Date 07/26/2022

Event Type  malfunction  

Event Description

Consumer reported complaint for true metrix meter not turning on when a test strip was inserted.The customer had changed the battery less than one week ago.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 but no when a test strip was inserted.Customer advised that she is a doctor and that she is feeling dizzy; customer was not going to seek any medical intervention.Customer stated that the meter is not working and she does not know what her blood sugar is and that she does not know how much insulin to take.Offered overnight shipping-customer satisfied.The test strip lot manufacturer¿s expiration date is (b)(6) 2023; product storage and open vial date were not disclosed.

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Manufacturer contacted customer in a follow-up call on (b)(6) 2022 to ensure the customer's condition had improved - able to establish contact with customer who stated she did not currently have any diabetic symptoms.No medical intervention since the last call was reported.Manufacturer contacted customer in a follow-up call on (b)(6)2022 to ensure the initial concern was resolved -able to establish contact with customer who stated they were experiencing symptoms of diarrhea and vomiting with use of alleged defective meter (not the replacement product).Customer states she could not speak at the time.Customer proceeded to thank ccr for calling and then disconnected the call.Manufacturer made several attempts to contact customer to ensure the customer was no longer experiencing symptoms and to ensure the replacement products resolved the initial concern - unable to establish contact with customer.

Manufacturer Narrative

Sections with additional information as of 21-sept-2022: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.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 strips tested within specifications.Most likely underlying root cause: mlc-025: strip inserted backwards or upside-down.

• 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: 15267224
• MDR Text Key: 305374289
• Report Number: 1000113657-2022-00456
• 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: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/26/2023
• Device Model Number: STRIP, TMX HMN 50CT24/CASE MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MY4462S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/26/2022
• Date Manufacturer Received: 08/25/2022
• 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