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

Model Number CONTROL, TRUE METRIX L1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Red Eye(s) (2038); Swelling/ Edema (4577)

Event Date 11/07/2022

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Outcomes attributed to adverse event: adverse event report is being submitted due to customer putting control solution in her eye causing redness and swelling and contacting her doctor due to putting the control solution in her eye.Control solution was returned - product evaluation in-process.Note 1: manufacturer contacted customer in a follow-up call on 11-nov-2022 to ensure that the customer's condition had improved - able to establish contact with customer who stated her symptoms have improved but she still has a little redness in the eye.Customer stated she had contacted her doctor who advised she could come in to the office but believed that she would be fine.Customer stated she does have a previously scheduled appointment with the doctor next month.Note 2: manufacturer contacted customer in additional follow-up call to ensure that the customer's condition had improved - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint that she had inadvertently put the control solution in her eye.Customer inquired about the ingredients in the control solution.The customer stated that her eye was a little red and swollen.Customer had contacted her doctor who had advised she contact manufacturer for the ingredients.Customer stated that she is not a diabetic, the control solution was part of her mother's supplies and that her mother had passed away (not related to diabetes or product use but because of congestive heart failure).Customer stated the doctor advised her to contact them back once she found out the ingredients in the control solution and they would let her know if she needed to come in the office.

Manufacturer Narrative

Sections with additional information as of 29-dec-2022: h6: updated fda's type of investigation, investigation findings, and investigation conclusions h10: 1 bottle of true metrix control solution was returned.Customer is not alleging a product defect.No complaint regarding performance.Product discarded.Added most likely underlying root cause onto case.No test strip lot number provided.Unable to perform retention testing.Most likely underlying root cause: mlc-009: use error caused or contributed to event.

• 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: 15906290
• MDR Text Key: 304717798
• Report Number: 1000113657-2022-00624
• Device Sequence Number: 1
• Product Code: JJX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Model Number: CONTROL, TRUE METRIX L1
• Device Lot Number: 1BC1B46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/07/2022
• Date Manufacturer Received: 12/06/2022
• 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