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 Codes	Fatigue (1849); Hyperglycemia (1905)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-062: user had poor technique.Note 1: manufacturer contacted customer in a follow-up call on (b)(6) 2023 to ensure the customer's condition had improved - able to establish contact with customer who stated his condition had improved and he did not currently have any diabetic symptoms.Customer reported medical intervention since the last call, stating he had gone to the er on ()b)(6) 2023.The customer's blood glucose test result when at the hospital had been 504 mg/dl; the diagnosis was high blood glucose and customer had been treated with fluids to stabilize him.Customer had been discharged on (b)(6) 2023; no new medications or health care program had been suggested by a health care professional.Note 2: manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.
Event or Problem Description
Consumer had initially reported complaint for e-5 error.Wife is calling on behalf of the customer.Customer was using test strip lot zy4480s, which was not being stored according to specification (bathroom).The customer did have another vial of test strips that had been stored and handled correctly: lot za4878s, manufacturer¿s expiration date is 02/29/2024 and opened day of call.During the call, a blood test was performed by the customer am fasting and produced test result of hi using true metrix meter and test strip lot za4878s.The customer¿s expected blood glucose test result range was not disclosed.The customer reported feeling tired; medical attention was not needed at the time of the call.The meter memory was not reviewed for previous test result history.
Additional Manufacturer Narrative
Sections with additional information as of 09-may-2023: 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.

• 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: 16713960
• Report Number: 1000113657-2023-00196
• Device Sequence Number: 1700484
• Product Code: NBW
• UDI-Device Identifier: 00021292007829
• UDI-Public: (01)00021292007829
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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: 02/29/2024
• Device Model Number: STRIP, TMX WGN 25CT24/CS MG/DL #383237
• Device Lot Number: ZA4878S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/17/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/09/2023
• 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: Hospitalization
• Patient Sex: Unknown