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	Low Test Results (2458)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	04/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-58: user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Note: manufacturer contacted customer in a follow-up call on 28-apr-2020 to ensure that the customer's condition improved - able to establish contact with customer and stated condition improved.Customer did not have any diabetic symptoms and no medical intervention since initial cal.Customer ran a blood test using truefocus meter and obtained a result of 177 mg/dl non-fasting.
Event or Problem Description
Consumer reported complaint for lo blood glucose test results.The customer is concerned with test results obtained of lo.Customer just started to use the truefocus meter on day of call.The customer did not know their expected blood glucose test result range.The customer reported feeling dizzy, no medical attention was required at the time of the call.During the call, a blood test was performed by the customer non-fasting and produced test result of 135 mg/dl using truefocus meter; fifteen minutes later customer reported feeling fine.The test strip lot manufacturer¿s expiration date is 08/29/2020 and open vial date is (b)(6) 2020.The meter memory was not reviewed for previous test result history.
Additional Manufacturer Narrative
Sections with additional information as of 27-aug-2020: h6: updated fda's method, result, and conclusion codes.H10: meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed by contract manufacturer using test strips from the same lot.Retention strip lot tested and passed.Corrected sections as of 27-aug-2020: h10: most likely underlying root cause corrected from "mlc-58: user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test" to "mlc-134: user has low glucose value".

• 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: 10089399
• Report Number: 1000113657-2020-00333
• Device Sequence Number: 2379654
• Product Code: NBW
• UDI-Device Identifier: 00021292007744
• UDI-Public: (01)00021292007744
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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,Followup
• Report Date (Section B): 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/29/2020
• Device Model Number: METER, WGN TRUE FOCUSMETER ONLY MG/DL 956968
• Device Lot Number: NV1000
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/27/2020
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1