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 Lethargy (2560); No Code Available (3191)

Event Date 12/23/2020

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Adverse event report is being submitted due to symptoms related to diabetes ¿ dry mouth and is feeling very lethargic.Note: manufacturer contacted customer several times in a follow-up calls to ensure the patient condition improved and the replacement products resolved the initial concern - unable to establish contact with customer at this time.

Event Description

Consumer initially reported complaint for error message (e-5).(b)(6) is calling on behalf of the customer.During the call, a blood test was performed by the customer and produced test result of hi using the meter.At the time of the call the customer reported symptoms of dry mouth and feeling lethargic; medical attention was not needed at the time.Caller/customer advised that customer does not know her expected range and that her results have been "all over".Customer was not using the proper testing technique.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 04/28/2022 and test strips were opened one week ago.The meter memory was not reviewed for previous test result history.Customer declined to provide further information and further troubleshooting.

Manufacturer Narrative

Sections with additional information as of 11-feb-2021: h6: updated fda's method, result, and conclusion codes.H10: test strips were not returned for evaluation.Meter was returned for evaluation.Product testing was performed and no defect found.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: 11189639
• MDR Text Key: 230003040
• Report Number: 1000113657-2021-00043
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2022
• Device Model Number: STRIP, TMX CVS 100CT12/CASE MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MX4419S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Distributor Facility Aware Date: 12/23/2020
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other