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

Model Number	METER, WGN TRUE FOCUSMETER ONLY MG/DL 956968
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Codes	Hypoglycemia (1912); Increased Appetite (4570)
Date of Event	12/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer reported complaint for dead meter.Customer had purchased the true focus meter a month ago.The test strips are expired: manufacturer¿s expiration date is 09/30/2023 and open vial date was not disclosed.Customer also stated that she could not find the battery for the meter.The customer feels well and did not report any symptoms.Customer stated that last night she didn't eat well; due to the chemotherapy she had lost her appetite.Customer stated this morning she wasn't feeling well, she was extremely hungry, and she had called 911.The paramedics had tested the customer's blood glucose and obtained result of 50 mg/dl fasting.The diagnosis was low blood glucose and customer was given glucose tablets.Customer's blood glucose was tested an hour later and it was 90 mg/dl non fasting.Paramedics had inserted a new battery in the true focus and the meter wasn't coming on; customer was advised to return to pharmacy.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).B2: adverse event report is being submitted due to customer contacting paramedics due to symptoms (extreme hunger).Meter and test strips were not returned for evaluation.Note: manufacturer made several attempts to contact customer to ensure the customer was no longer experiencing symptoms and to ensure the customer¿s initial concern was resolved- unable to establish contact with customer.

• 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: 18495421
• Report Number: 1000113657-2024-00017
• Device Sequence Number: 12508822
• Product Code: NBW
• UDI-Device Identifier: 00021292007744
• UDI-Public: (01)00021292007744
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 01/11/2024

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: 09/30/2023
• Device Model Number: METER, WGN TRUE FOCUSMETER ONLY MG/DL 956968
• Device Lot Number: NY1011
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/18/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 01/11/2024
• 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