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 High Test Results (2457)

Patient Problems Urinary Frequency (2275); Dry Mouth (4485)

Event Date 08/12/2022

Event Type  Injury  

Event Description

Consumer reported complaint for hi and high blood glucose test results.The customer is concerned with test results from results obtained of hi; customer stated the hi had been obtained that day.Customer also stated that a few days prior he he had obtained results in the 400's mg/dl.The customer does not know their expected blood glucose test result range.At the time of the call the customer reported symptoms of dry mouth and frequent urination.Customer stated that he has been having these symptoms for the past three weeks.Customer stated that he was going to contact his doctor.During the call, a back to back blood test was not performed by the customer.The product is stored according to specification in the living room.The test strip lot manufacturer¿s expiration date is 01/31/2023 and the test strips were opened about 1-2 months prior to call.The meter memory was not reviewed for previous test result history.

Manufacturer Narrative

Internal report reference number: (b)(4).Adverse event report is being submitted due to symptoms related to diabetes: dry mouth and frequent urination and for customer contacting doctor due to meter results.Meter and test strips were not returned for evaluation.Note 1: manufacturer contacted customer in a follow-up call on 16-aug-2022 to ensure the customer's condition had improved - able to establish contact with customer who stated that he was still currently experiencing diabetic symptoms.Customer stated that since the last call he had contacted his doctor; customer stated the doctor advised him to lower his blood glucose and that she would see him at his upcoming appointment on (b)(6) 2022.Note 2: manufacturer contacted customer in a follow-up call on 19-aug-2022 to ensure the customer's condition had improved - able to establish contact with customer who stated he was still experiencing frequent urination.No additional medical intervention since the last call was reported.Note 3: manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved and that the replacement products resolved the initial concern - unable to establish contact with customer at this time.

Manufacturer Narrative

Sections with additional information as of 04-oct-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-018: user has high glucose value.

• 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: 15369717
• MDR Text Key: 299367687
• Report Number: 1000113657-2022-00477
• 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,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Model Number: STRIP, TMX HMN 50CT24/CASE MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZY4457S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/12/2022
• Date Manufacturer Received: 09/15/2022
• 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