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

Model Number	STRIP, TMX WGN 25CT24/CS MG/DL #383237
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Diaphoresis (2452)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from meter to meter comparison of 158 mg/dl using true metrix meter and 60 mg/dl using another device.Customer reported the comparison tests had been performed am fasting the day prior and that they had been sweating at the time.The customer¿s expected am fasting blood glucose test result is < 126 mg/dl.At the time of the call, the customer felt well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results and reported symptom(s).During the call, meter to meter comparison blood tests were performed by the customer pm fasting and produced test results of 214 mg/dl using true metrix meter and 108 mg/dl using another device.The product is stored according to specification in the dining room.The test strip lot manufacturer¿s expiration date is 09/28/2024 and open vial date is 05/17/2023.The meter memory was not reviewed for previous test result history.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Test strips were not returned for evaluation - customer had returned the incorrect test strips.Meter was returned for evaluation.Product testing was performed and no defect found on returned meter.Control solution was also returned ((2bc1b53, no product complaint was alleged by the customer).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 26-may-2023 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
Additional Manufacturer Narrative
Sections with additional information as of 05-jul-2023: h6: updated fda¿s type, findings and conclusions codes.H10: test strips were not returned for evaluation - customer had returned the incorrect test strips.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.

• Brand Name: TRUE METRIX
• Common Device Name: 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: 17126021
• Report Number: 1000113657-2023-00322
• Device Sequence Number: 12593332
• Product Code: NBW
• UDI-Device Identifier: 00021292007829
• UDI-Public: (01)00021292007829
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/28/2024
• Device Model Number: STRIP, TMX WGN 25CT24/CS MG/DL #383237
• Device Lot Number: ZB5193S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/18/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown