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

Model Number STRIP, TMX CVS 50CT24/CASE MG/DL

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2022

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 (b)(6) 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 high blood glucose test results.The customer is concerned with test results from results obtained of 175, 173, 146 and 234 mg/dl.The customer¿s expected am fasting blood glucose test result range is 90-120 mg/dl and expected 2 hour post meal expected range is 120-150 mg/dl.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call, a blood test was performed by the customer non-fasting and produced test result of 168 mg/dl using true metrix air meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 04/18/2024 and test strips were opened three weeks prior to call.The meter memory was reviewed for previous test result history: result 1: 175 mg/dl date: on (b)(6) 2022 time: 10:21 am fasting, result 2: 173 mg/dl date: on (b)(6) 2022 time: 9:11 am fasting, result 3: 146 mg/dl date: on (b)(6) 2022 time: 4:43 am fasting, result 4: 234 mg/dl date: on (b)(6) 2022 time: 8:28 pm 2 hrs.After meal, result 5: 128 mg/dl date: on (b)(6) 2022 time: 4:13 pm 2 hrs.After meal.

Manufacturer Narrative

Sections with additional information as of 12-jan-2023: h6: updated fda¿s type, findings and conclusions 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 passed within specifications.Most likely underlying root cause: mlc-062: user had poor technique.

• Brand Name: TRUE METRIX AIR
• 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: 16026731
• MDR Text Key: 308369829
• Report Number: 1000113657-2022-00665
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150052
• 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: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: STRIP, TMX CVS 50CT24/CASE MG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: ZA4931S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/05/2022
• Date Manufacturer Received: 12/21/2022
• 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