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

Model Number STRIP, GNP TMX 50CT MMMG/DL

Device Problem High Test Results (2457)

Patient Problems Muscle Weakness (1967); Blurred Vision (2137); Constipation (3274)

Event Date 09/08/2022

Event Type  Injury  

Event Description

Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 276, 238, 261, 233 and 222 mg/dl.The customer¿s expected blood glucose test results are 150 mg/dl fasting am, 198 mg/dl non-fasting afternoon and 189-199 mg/dl non-fasting evening.At the time of the call the customer reported feeling weak, constipated and having blurry vision.Medical attention was not needed at the time.During the call, a blood test was performed by the customer non-fasting and produced test result of 298 mg/dl using true metrix meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 01/14/2023 and test strips were opened two weeks prior to call.The meter memory was reviewed for previous test result history: result 1: 276 mg/dl, date: 09-08, time: 08:59 am, non-fasting, result 2: 238 mg/dl, date: 09-07, time: 11:44 am, fasting, result 3: 261 mg/dl, date: 09-07, time: 11:43 am, fasting, result 4: 233 mg/dl, date: 09-07, time: 08:04 am, fasting, result 5: 222 mg/dl , date: 09-07, time: 02:00 am, fasting.

Manufacturer Narrative

Internal report reference number: (b)(4).Outcomes attributed to adverse event: adverse event report is being submitted due to symptoms related to diabetes: weak, blurry vision and constipation.Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved and that the replacement products resolved the initial concern - unable to establish contact with customer at this time.

Manufacturer Narrative

Sections with additional information as of 19-oct-2022: 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 tested within specifications.Most likely underlying root cause: mlc-058: user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.

• 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: 15495536
• MDR Text Key: 300700084
• Report Number: 1000113657-2022-00520
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 0002129200783
• UDI-Public: (01)0002129200783
• 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: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2023
• Device Model Number: STRIP, GNP TMX 50CT MMMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZY4427S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/08/2022
• Date Manufacturer Received: 09/29/2022
• 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
• Patient Outcome(s): Other