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

Model Number STRIP, TMX CVS 100CT12/CASE MG/DL

Device Problem High Test Results (2457)

Patient Problems Headache (1880); Sweating (2444)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on 17-dec-2021 to ensure the patient condition improved and initial concern is resolved - able to establish contact with customer and stated is the customer's condition had improved and did not currently have any diabetic symptoms.No medical intervention since the last call was reported.

Event Description

Consumer reported complaint for hi blood glucose test results.Granddaughter is calling on behalf of the customer.The customer is concerned with test results from results obtained of hi.Granddaughter stated the customer had tested 30 minutes prior to call and had obtained hi.Granddaughter did not know the customer's expected blood glucose test result range.At the time of the call the customer reported sweating and having a headache; medical attention was not needed at the time.During the call, a back to back blood test was not performed by the customer.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 12/31/2021 and test strips were open two weeks ago.The meter memory was not reviewed for previous test result history.

Manufacturer Narrative

Sections with additional information as of 25-feb-2021: h6: updated fda's method, result, and conclusion 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 and passed.Most likely underlying root cause: mlc-018: user has high glucose value.

• 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
• MDR Report Key: 11147555
• MDR Text Key: 230002702
• Report Number: 1000113657-2021-00018
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836
• Combination Product (y/n): N
• PMA/PMN Number: K140100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2021
• Device Model Number: STRIP, TMX CVS 100CT12/CASE MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MX4312S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/16/2020
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1