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

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

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

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

Event Date 03/15/2024

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).B2: product problem is being submitted due to control solution was not returned/evaluated.Control solution was not returned for evaluation.Meter and test strips were returned for evaluation.Product testing was performed and no defect found on returned meter and test strips.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: mlc-055: user had an inaccurate reference: competitor¿s meter: the end user is comparing results obtained from trividia¿s bgm system to the results from a competitor¿s bgm system.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2024 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

Event Description

Consumer reported complaint for high control test result and high blood glucose test results.The customer is concerned with test results from blood glucose test results obtained of 171, 138, 169, 149 and 205 mg/dl and from control test result of 177 mg/dl.Customer also stated when she had obtained the blood glucose test result of 205 mg/dl she had tested using another brand meter and had obtained result of 106 mg/dl.The customer does not know her expected blood glucose test result range.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 199 mg/dl using true metrix meter; customer stated she had just taken medication 15 minutes before testing.The product is stored according to specification in the dining room.The test strip lot manufacturer¿s expiration date is 10/24/2024 and test strips were opened 20 days prior to the call.The meter memory was reviewed for previous test result history: result 1 : 171 mg/dl date: on (b)(6) 2024 , time: 6:40am fasting.Result 2 : 138 mg/dl date: on (b)(6) 2024, time: 6:15am fasting.Result 3 : 169 mg/dl date: on (b)(6) 2024 , time: 9:09am fasting.Result 4 : 149 mg/dl date: on (b)(6) 2024 , time: 6:52am fasting.Result 5 : 205 mg/dl date: on (b)(6) 2024 , time: 7:16am fasting.

• 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: 19078115
• MDR Text Key: 339785152
• Report Number: 1000113657-2024-00143
• 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: Replace
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: STRIP, TMX HMN 50CT24/CASE MG/DL
• Device Lot Number: ZB5222S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Distributor Facility Aware Date: 03/15/2024
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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