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

Model Number STRIP, SUNMARK TMX 50CTMG/DL

Device Problem High Test Results (2457)

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

Event Date 11/21/2022

Event Type  malfunction  

Event Description

Consumer reported complaint for high and erratic blood glucose test results.The customer is concerned with test results from results obtained of 157, 150, 202 and 209 mg/dl.The customer¿s expected blood glucose test result ranges are 90-130 mg/dl am fasting and 140 mg/dl 2 hours post meal.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.The customer was not using the proper back to back testing technique.During the call, a back to back blood test was performed by the customer non-fasting and produced test results of 275 mg/dl and 268 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 06/16/2023 and open vial date is 2 months ago.The meter memory was reviewed for previous test result history: result 1: 157 mg/dl, date: (b)(6) 2022, time: 8:30 am, fasting result 2: 150 mg/dl, date: (b)(6) 2022, time: 1:30 pm, 2 hrs.After meal.Result 3: 150 mg/dl, date: (b)(6) 2022, time: 2:48 pm, 2 hrs.After meal.Result 4: 202 mg/dl, date: (b)(6) 2022, time: 2:47 pm, 2 hrs.After meal.Result 5: 209 mg/dl, date: (b)(6) 2022, time: 3:27 pm, 2 hrs.After meal.

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-062: user had poor technique.Note: manufacturer contacted customer in several follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.

Manufacturer Narrative

Sections with additional information as of 12-jan-2023: 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 within specifications.

• 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: 15980456
• MDR Text Key: 308146149
• Report Number: 1000113657-2022-00652
• 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: 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: 12/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/16/2023
• Device Model Number: STRIP, SUNMARK TMX 50CTMG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: ZY4583S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/21/2022
• Date Manufacturer Received: 12/20/2022
• 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