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

Model Number	STRIP, TF WGN 50CTMG/DL 956970
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	05/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer reported complaint for error messages (e-2 and e-5) and low blood glucose test results using two true focus meters; additional internal report reference number (b)(4).Customer stated she had purchased both meters the week prior to the call.The customer is concerned with test results from meter to meter comparison results using the true focus meters of 63 and 90 mg/dl am fasting.Customer did not disclose which true focus meter gave which result.The customer¿s expected blood glucose test result ranges are 140- 150 mg/dl am fasting, 170- 200 mg/dl pm fasting and 320 mg/dl pm fasting post dinner.The customer feels well and did not report any symptoms.No medical attention due to the blood glucose test results obtained was reported at the time of the initial call.During the call, a back to back blood test was not performed by the customer.The product is stored according to specification in the dining room.The test strip lot manufacturer¿s expiration date is 03/20/2024 and open vial date is (b)(6) 2022.The meter memory was not reviewed for previous test result history (customer has vision issue).Customer declined a replacement and stated that she would contact her doctor to get a prescription for a different brand meter.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Additional internal report reference number: (b)(4): same test strip lot number, different meter serial number.Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2022 to ensure that the initial concern was resolved - able to establish contact with customer who stated that the day after the initial call she had gone to the hospital; customer stated that she had gone to the hospital due to the low blood glucose test results obtained.No further information was provided.Customer stated that she had since obtained a different meter and disconnected the call.

• Brand Name: TRUE FOCUS
• 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: 14735764
• Report Number: 1000113657-2022-00346
• Device Sequence Number: 5800246
• Product Code: NBW
• UDI-Device Identifier: 00021292008956
• UDI-Public: (01)00021292008956
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2022

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: 03/20/2024
• Device Model Number: STRIP, TF WGN 50CTMG/DL 956970
• Device Lot Number: NA1015
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/23/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 06/17/2022
• 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