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

Model Number	CONTROL, TRUE METRIX L1
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Adverse event report is being submitted due to customer contacting eye doctor due to using control solution in her eyes.Control solution was not returned to manufacturer.Note 1: manufacturer contacted customer in a follow-up call on 01-feb-2022 to ensure the customer's condition had improved - able to establish contact with customer who stated that she the skin around the eyes was no longer red and that her eyes were fine.Customer stated she had contacted the eye doctor who had advised her to wash the eyes with water.Note 2: manufacturer contacted customer in several follow-up calls to ensure the replacement control solutions had been received and were working as intended - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported that she had put one drop of true metrix control solution in each of her eyes: control level one, lot # 1bc1b44, manufacturer¿s expiration date is 12/31/2022.Daughter is calling on behalf of the customer.Customer uses eye drops at night and had used the control solution the night before thinking it was the eye drops.Customer had woke up that morning and the skin around her eyes was red; customer stated that the eyes were not red, it was the skin around the eyes.Customer stated she had not rinsed her eyes.Customer stated that she was not experiencing any pain in her eyes.Customer stated she was going to contact the eye doctor.

• Brand Name: TRUE METRIX
• Common Device Name: 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: 13603433
• Report Number: 1000113657-2022-00102
• Device Sequence Number: 12210583
• Product Code: JJX
• UDI-Device Identifier: 00021292008390
• UDI-Public: 021292008390
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2022
• Device Model Number: CONTROL, TRUE METRIX L1
• Device Catalogue Number: RE4H01-81
• Device Lot Number: 1BC1B44
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/31/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown