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	High Test Results (2457)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	05/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Note: 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 reported complaint for high blood glucose test results.Husband is calling on behalf of the customer.The customer is concerned with test results from meter to meter comparison test results of 103mg/dl using true focus meter, 83mg/dl using paramedics meter and 72mg/dl using another device.The customer¿s expected am fasting blood glucose test result range is 80-120mg/dl and expected non-fasting blood glucose test result range is 120-200mg/dl.The customer feels well and did not report any symptoms.Husband stated that on (b)(6) 2022 customer was unconscious and emt's had been called.The customer's blood glucose test result when checked by the emt's had been 39mg/dl non-fasting.The emt's were able to raise customer's blood glucose to 83mg/dl; husband did not disclose what treatment customer had received.The meter to meter comparison tests were performed at this time.The diagnosis was hypoglycemia.Customer did not need to go to the hospital.During the call, a back to back blood test was performed by the customer non-fasting and produced test result of 202mg/dl using true focus meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 03/31/2023 and open vial date is 2 weeks ago.The meter memory was reviewed for previous test result history: result 1: 103 mg/dl; date: 05-29; time: 10:44 pm; non-fasting.Result 2: 91 mg/dl; date: 05-29; time: 10:23 pm; non-fasting.Result 3: 92 mg/dl; date: 05-29; time: 07:36 pm; non-fasting.Result 4: 84 mg/dl; date: 05-23; time: 10:24 am; fasting.Result 5: 61 mg/dl; date: 05-21; time: 05:20 pm; non-fasting (not concerned.

• 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: 14794886
• Report Number: 1000113657-2022-00357
• Device Sequence Number: 12246041
• Product Code: NBW
• UDI-Device Identifier: 00021292008956
• UDI-Public: (01)00021292008956
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K131013
• 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
• Report Date (Section B): 06/23/2022

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: 03/31/2023
• Device Model Number: STRIP, TF WGN 50CTMG/DL 956970
• Device Lot Number: NY1008
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/31/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 06/23/2022
• 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: Required Intervention
• Patient Sex: Unknown