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 Code	Fatigue (1849)
Date of Event	09/17/2020
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-61: improper use / mishandled by end user note: manufacturer contacted customer in a follow-up call to ensure that the customer's condition improved - unable to establish contact with customer at this time.No product notification letter sent since no customer address on file.
Event or Problem Description
Consumer reported complaint for low battery symbol.Customer stated the battery had not been changed and that she had only been using the truefocus meter for two weeks.During the call, the truefocus meter powered on using the power button and when a test strip was inserted.The low battery symbol was not on.The meter turned off when the power button was held.The truefocus meter displayed the blood drop to indicate it was ready to perform a test.At the time of the call the customer reported feeling tired and off balance; medical attention was not needed at the time.During the call, a blood test was performed by the customer fasting and produced test result of 119 mg/dl using truefocus meter; customer was satisfied with the result obtained.

• 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
• MDR Report Key: 10680428
• Report Number: 1000113657-2020-00751
• Device Sequence Number: 14200856
• Product Code: NBW
• UDI-Device Identifier: 00021292007744
• UDI-Public: (01)00021292007744
• 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): 10/14/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/24/2022
• Device Model Number: METER, WGN TRUE FOCUSMETER ONLY MG/DL 956968
• Device Lot Number: NX1002
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other