MAUDE Adverse Event Report: TRIVIDIA HEALTH INC TRUE METRIX AIR; 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 Dysphagia/ Odynophagia (1815); Dizziness (2194); Sleep Dysfunction (2517)

Event Date 03/01/2022

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Adverse event report is being submitted due to customer contacting doctor due to symptoms.Meter and test strips were not returned for evaluation.Note 1: manufacturer contacted customer in a follow-up call on (b)(6) 2022 to ensure that the customer's condition had improved - able to establish contact with customer who stated her condition had not improved and that she was feeling dizzy.Customer stated she was going to seek medical attention and go to the er.Note 2: manufacturer contacted customer in a follow-up call on (b)(6) 2022 to ensure that the customer's condition had improved - able to establish contact with customer who stated her condition had not improved and that she was dizzy and not able to eat or sleep.Customer stated she was going to contact her doctor due to experiencing more symptoms.No medical intervention since the last call was reported.Customer had tested using the true metrix air meter and had obtained a result of 81mg/dl fasting.Note 3: manufacturer contacted customer in a follow-up call on (b)(6) 2022 to ensure that the customer's condition had improved - able to establish contact with customer who stated her condition had improved and that she did not currently have any diabetic symptoms.Customer had contacted her doctor prescribed customer nausea medication.Customer did not disclose whether or not her symptoms were related to her diabetes.Customer stated that the true metrix air meter and test strips were working fine.

Event Description

Consumer reported complaint for error message (e-3).At the time of the call the customer reported feeling dizzy.Customer stated she had not eaten anything all day.Medical attention was not needed at the time.During the call, a blood test was performed by the customer fasting and produced test result of 73 mg/dl using true metrix air meter; customer was satisfied with the result obtained.The product is stored according to specification.The test strip lot manufacturer¿s expiration date is 06/23/2023 and open vial date is (b)(6) 2022.What is the customer requesting training on or assistance with: the customer called because the meter display e-3 when test strip inserted.What information was provided/ or what was assistance was provided to customer: instructed customer what can cause e-3.The customer perform blood test result 73 mg/dl fasting.-the customer is feeling dizzy now symptoms related to diabetes customer states she haven't eat anything all day.Customer does need to seek medical attention.Customer was educated with proper testing technique and storage.Is customer satisfied with what was provided will follow up.

Manufacturer Narrative

Sections with additional information as of 11-may-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-030: user applied blood to strip before inserting strip into meter.

• Brand Name: TRUE METRIX AIR
• 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: 13934105
• MDR Text Key: 293150495
• Report Number: 1000113657-2022-00176
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 0002129200783
• UDI-Public: (01)0002129200783
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/23/2023
• Device Model Number: STRIP, TMX WGN 100CT12/CS MG/DL #383569
• Device Catalogue Number: REA4H01-01
• Device Lot Number: ZY4592S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/01/2022
• Date Manufacturer Received: 04/14/2022
• 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): Other