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

Model Number STRIP, WGN TMX 60CT 12/CASE MG/DL

Device Problem High Test Results (2457)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Nausea (1970)

Event Date 12/09/2022

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Outcomes attributed to adverse event: adverse event report is being submitted due to customer taking medication based on meter result.Meter and test strips were not returned for evaluation.Added most likely underlying root cause onto case as the complaint product was not returned for investigation.Most likely underlying root cause: mlc-057: user had an inaccurate reference: alternate meter: the end user is comparing results obtained from one of trividia¿s bgm system to the results from another trividia¿s bgm system note 1: manufacturer contacted customer in a follow-up call on 14-dec-2022 to ensure the customer's condition had improved.Able to establish contact with customer's daughter who stated that customer's condition had improved and the customer did not currently have any diabetic symptoms.No medical intervention since the last call was reported.Customer had tested using a new meter and daughter stated that her blood sugar was stable.Note 2: manufacturer contacted customer in a follow-up call on 19-dec-2022 to ensure the replacement products resolved the initial concern - able to establish contact with customer's daughter who stated that customer received the meter, but she is travelling and will be back home after the holidays.

Event Description

Consumer reported complaint for high blood glucose test results.Daughter is calling on behalf of the customer.The customer is concerned with test results from results obtained of 271 mg/dl non-fasting.After the result had been obtained, customer had injected insulin.Customer had re-tested, did not disclose how long after, and obtained a result of 151 mg/dl non-fasting.The customer does not know their expected blood glucose test result range.The product is stored according to specification in the living room.The test strip lot manufacturer¿s expiration date is 04/30/2024 and open vial date is three days ago.At the time of the call the customer reported symptoms of feeling tired, nausea and stomachache.Customer was going to seek medical attention.

Manufacturer Narrative

Sections with additional information as of 01-feb-2023: h3: device evaluated by manufacturer.H6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: customer returned incorrect strips-lot #za5015s.Correct meter was returned.Reported defect not reproduced on returned meter.Product evaluation has been completed and most likely underlying root cause selected.Retention testing was performed using test strips from the same lot.Retention strips tested within specifications most likely underlying root cause: mlc-057: user had an inaccurate reference: alternate meter: the end user is comparing results obtained from one of trividia¿s bgm system to the results from another trividia¿s bgm system.

• 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: 16078368
• MDR Text Key: 308531606
• Report Number: 1000113657-2022-00679
• 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: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: STRIP, WGN TMX 60CT 12/CASE MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZA4953S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/09/2022
• Date Manufacturer Received: 01/05/2023
• 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
• Patient Outcome(s): Other