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	Battery Problem (2885)
Health Effect - Clinical Code	Lethargy (2560)
Date of Event	08/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Adverse event report is being submitted due to symptoms related to diabetes: lethargy, tired.Meter and test strips were not returned for evaluation.Manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved and that the replacement products resolved the initial concern - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for low battery symbol.Daughter is calling on behalf of the customer.The battery had never been changed; customer had just obtained the true focus meter.At the time of the call, the customer was feeling lethargic and tired; medical attention was not needed at the time.The customer is using the correct battery in the correct orientation for the meter.During troubleshooting, done with the caller, the meter still shows low battery when the "s" button was pressed and when the strip was inserted.
Additional Manufacturer Narrative
Sections with additional information as of: 26-oct-2021 h3: was the device evaluated by the manufacturer (nova biomedical).H6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: meter was received and investigated by nova biomedical.External evaluation has been completed by nova biomedical.Reported defect not reproduced on returned meter.Added most likely underlying root cause: mlc-044 user has low battery.

• 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: 12468582
• Report Number: 1000113657-2021-00549
• Device Sequence Number: 17366311
• Product Code: NBW
• UDI-Device Identifier: 00021292007744
• UDI-Public: (01)00021292007744
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2021

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: 06/17/2023
• Device Model Number: METER, WGN TRUE FOCUSMETER ONLY MG/DL 956968
• Device Lot Number: NY1009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Distributor Facility Aware Date: 08/19/2021
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 10/26/2021
• 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