MAUDE Adverse Event Report: TRIVIDIA HEALTH INC TRUE METRIX GO; 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 Codes	Unspecified Infection (1930); Dizziness (2194); Polydipsia (2604)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for hi blood glucose test results.Husband is calling on behalf of the customer.The customer is concerned with test results from results obtained of hi.Husband stated that customer had been dizzy and thirsty on 11/15/2023.Husband stated that later after dinner the customer had felt better.Husband stated customer did not perform another blood test prior to going to bed.The customer¿s expected blood glucose test result range was not disclosed.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 symptoms.During the call, a back to back blood test was not performed by the customer.The test strip lot manufacturer¿s expiration date is 09/28/2024; product storage and open vial date were not disclosed.The meter memory was not reviewed for previous test result history.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot passed within specifications.Most likely underlying root cause: mlc-018: user has high glucose value.Note: manufacturer contacted customer in several follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.

• Brand Name: TRUE METRIX GO
• 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: 18300242
• Report Number: 1000113657-2023-00599
• Device Sequence Number: 3201640
• Product Code: NBW
• UDI-Device Identifier: 00021292007829
• UDI-Public: (01)00021292007829
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2023

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?: No
• Distributor Facility Aware Date: 11/16/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 12/11/2023
• 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