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

Model Number STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL

Device Problem Low Test Results (2458)

Patient Problem Presyncope (4410)

Event Date 08/08/2022

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 18-aug-2022 to ensure that the initial concern was resolved - able to establish contact with customer who stated is comfortable with the glucose readings from the product.

Event Description

Consumer reported complaint for low blood glucose test results.The customer is concerned with test results from results obtained of 62 mg/dl am fasting.The customer¿s expected am fasting blood glucose test result is 120 mg/dl.Customer stated he had been feeling lightheaded at the time the result of 62 mg/dl was obtained and had some sips of his glucerna.Customer then tested using another device and obtained 78 mg/dl non-fasting and stated he felt much better.At the time of the call the customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The customer was not using the proper testing technique.During the call, a blood test was performed by the customer non-fasting and produced test result of 208 mg/dl using true metrix meter.The product is stored according to specification in the dining room.The test strip lot manufacturer¿s expiration date is 02/20/2023; customer was unsure of open vial date but stated it was not longer than 4 months ago.The meter memory was not reviewed for previous test result history.

Manufacturer Narrative

Sections with additional information as of 27-sep-2022: 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 passed within specifications.Most likely underlying root cause: mlc-062: user had poor technique.

• 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: 15348323
• MDR Text Key: 305691855
• Report Number: 1000113657-2022-00470
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140100
• 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: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/20/2023
• Device Model Number: STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MY4452S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/08/2022
• Date Manufacturer Received: 09/06/2022
• 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