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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Control solution was not returned for evaluation.Note 1: manufacturer contacted customer in a follow-up call on 21-jul-2021 to ensure the customer's condition had improved - able to establish contact with customer who stated that she had redness in her eye but that it was there from before she had put the control solution in.Customer stated there was no change since she put the control solution in her eye.Customer stated the redness is due to shingles in her eye which she has had for about a year.Customer stated she did not contact her doctor.Note 2: manufacturer contacted customer in a follow-up call on 03-aug-2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.Customer did not report any further medical attention.
Event or Problem Description
Consumer reported that she had put one drop of true metrix control solution in her eye; control level one, lot # 1bc1b46, manufacturer¿s expiration date is 03/31/2023.Pharmacist is calling on behalf of the customer then conference the customer on the line.At the time of the call the customer was not experiencing any symptoms as a result; customer had contacted the pharmacist who advised customer to rinse her eye with water use artificial tears.Customer stated she was going to contact her 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
• MDR Report Key: 12324709
• Report Number: 1000113657-2021-00484
• Device Sequence Number: 14487243
• Product Code: NBW
• UDI-Device Identifier: 00021292008390
• UDI-Public: 021292008390
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/16/2021

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: 03/31/2023
• Device Model Number: CONTROL, TRUE METRIX L1
• Device Catalogue Number: RE4H01-81
• Device Lot Number: 1BC1B46
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention