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

Model Number STRIP, TMX HNO 50CT24/CS MG/DL

Device Problem High Test Results (2457)

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

Event Date 11/28/2022

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were returned - product evaluation in-process.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2022 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 blood glucose test results.The customer is concerned with test results from results obtained of 246 and 204 mg/dl.The customer¿s expected fasting blood glucose test result range is 120-140 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 back to back blood test was not performed by the customer.Product storage was not disclosed.The test strip lot manufacturer¿s expiration date is 03/15/2024; customer could not recall the open vial date and was unsure if the test strips had been opened for more than four months.The customer did not have another vial of test strips that had been stored and handled correctly.The meter memory was reviewed for previous test result history: result 1: 254 mg/dl date: on (b)(6) time: 12:14 pm fasting 2-3 hours after breakfast, result 2: 170 mg/dl date: on (b)(6) time: 1:18 pm fasting 2-3 hours after breakfast, result 3: 204 mg/dl date: on (b)(6) time: 7:49 am fasting, result 4: 246 mg/dl date: on (b)(6) time: 7:48 am fasting, result 5: 152 mg/dl date: on (b)(6) time: 11:43 am fasting.

Manufacturer Narrative

Sections with additional information as of 19-jan-2023: h3: was the device evaluated by the manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: meter and test strips (2 vials) were returned for evaluation.Product testing was performed and no defect found.Second returned test strip vial acceptable with lab meters.Retention testing was performed using test strips from the same lot.Retention strip lot tested 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: 16028034
• MDR Text Key: 308377032
• Report Number: 1000113657-2022-00668
• Device Sequence Number: 1
• Product Code: NBW
• 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,Followup
• Report Date: 01/19/2023

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 Expiration Date: 03/15/2024
• Device Model Number: STRIP, TMX HNO 50CT24/CS MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZA4895S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/28/2022
• Date Manufacturer Received: 12/29/2022
• 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