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

Model Number STRIP, WGN TMX 60CT 12/CASE MG/DL

Device Problem High Test Results (2457)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/13/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Meter and test strips were not returned for evaluation.Note 1: manufacturer contacted customer in a follow-up call on 16-may-2022 to ensure that the customer's condition had improved - able to establish contact with customer who stated her condition had improved and she did not currently have any diabetic symptoms.No medical intervention since the last call was reported.Customer had tested that morning and obtained 158mg/dl fasting and was satisfied with the result.Note 2: manufacturer contacted customer in a follow-up call on 24-may-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.

Event Description

Consumer called for assistance with performing blood test.Husband is calling on behalf of the customer.During the call, a blood test was performed by the customer fasting and produced test result of hi using true metrix meter.Husband stated that he knows customer's glucose is very high.The customer¿s expected am fasting blood glucose test result is 130mg/dl and expected pm non-fasting blood glucose test result is 200mg/dl.The customer reported "feeling loopy"; medical attention was not needed at the time of the call.The test strip lot manufacturer¿s expiration date is 11/30/2023; product storage and open vial date were not disclosed.The meter memory was reviewed for previous test result history: result 1 : hi mg/dl, date: (b)(6), time: 03:16 pm, fasting.

Manufacturer Narrative

Sections with additional information as of 18-jul-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: 14649371
• MDR Text Key: 301496817
• Report Number: 1000113657-2022-00328
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292009120
• UDI-Public: (01)00021292009120
• 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: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Model Number: STRIP, WGN TMX 60CT 12/CASE MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZA4790S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/13/2022
• Date Manufacturer Received: 06/21/2022
• 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