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

Model Number STRIP, TMX WGN 100CT12/CS MG/DL #383569

Device Problem Image Display Error/Artifact (1304)

Patient Problems Chest Pain (1776); Headache (1880); Nausea (1970); Vomiting (2144); Dizziness (2194)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Note 1: manufacturer contacted customer in a follow-up call on 06-oct-2021 to ensure the customer's condition had improved - able to establish contact with customer who stated that he did not currently have any diabetic symptoms.Customer stated he had gone to the hospital on (b)(6) 2021 due to symptoms of headache, nausea, dizziness and vomiting.Customer was treated (unknown medication) to stabilize him and given fluids.Customer stated the diagnosis, had been related to his diabetes, but he didn¿t understand what they had said because they were speaking in english, and he only speaks spanish.Customer had been discharged the same day.Customer stated that they had given him pain killers and medication for his diabetes, and recommended to follow up with his doctor.Customer stated that he couldn¿t use the meter because he tried this morning and all he got was an e-3 error.Note 2: manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for error message (e-3).Friend is calling on behalf of the customer.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 02/28/2023 and open vial date is (b)(6) 2021.The customer was not using the proper testing technique.During the call, a blood test was performed by the customer fasting and produced test result of 239mg/dl using true metrix meter; customer stated he did not know his expected blood glucose test result range and was not concerned with the result.At the time of the call, the customer reported feeling symptoms of headache, chest pain and a bitter taste in his mouth.Customer stated he was going to contact his doctor to let him know about his symptoms and the blood glucose result.

Manufacturer Narrative

Sections with additional information as of 17-nov-2021: 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-030: user applied blood to strip before inserting strip into meter.

• 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: 12694062
• MDR Text Key: 278414948
• Report Number: 1000113657-2021-00674
• 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: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Model Number: STRIP, TMX WGN 100CT12/CS MG/DL #383569
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MY4475S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/01/2021
• Date Manufacturer Received: 11/04/2021
• 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