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	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	Headache (1880)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).B2: adverse event report is being submitted due to symptoms related to diabetes: headache.Meter and 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-020: user's test strip had poor storage.Note 1: manufacturer contacted customer in a follow-up calls on 26-sep-2023, 27-sep-2023, 28-sep-2023 and 29-sep-2023 to ensure the customer's condition had improved - able to establish contact with customer who stated he still had the headache.No medical intervention since the last call was reported.Note 2: manufacturer contacted customer in a follow-up call on 03-oct-2023 to ensure the customer's condition had improved and that the replacement products resolved the initial concern - able to establish contact with customer who stated he still had the headache.Customer stated he did not contact the doctor regarding the headache.Customer stated that the replacement products resolved the initial concern.
Event or Problem Description
Consumer reported complaint for error messages (e-2, e-3 and e-1).The customer reported having a headache; medical attention was not needed at the time of the call.During the call, a back to back blood test was not performed by the customer.The product is not stored according to specification (stored in customer's car).The test strip lot manufacturer¿s expiration date is 02/28/2025 and open vial date was not disclosed.The customer did not have another vial of test strips that had been stored and handled correctly.

• 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: 17956273
• Report Number: 1000113657-2023-00512
• Device Sequence Number: 7007308
• Product Code: NBW
• UDI-Device Identifier: 00021292007829
• UDI-Public: (01)00021292007829
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2025
• Device Model Number: STRIP, TMX WGN 25CT24/CS MG/DL #383237
• Device Lot Number: ZB5349S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/25/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 10/18/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown