MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUETRACK; BLOOD GLUCOSE SYSTEM

Model Number	TRUETRACK
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Headache (1880)
Date of Event	05/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with defect found.On the qc investigation on 6/15/2018 resulted in defect found; battery contacts damaged.Final root cause: bent positive battery terminal due to user mechanical stress.Test strip udi# (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern and to ensure the customer's condition since the initial call; unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for dead meter accompanied by symptoms.Caregiver is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer did report symptom of having a headache.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 06/27/2020 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Customer states she has a headache and caregiver states they will not seek medical attention at this time.Meter is not coming on and customer is testing with alternate meter that read high.A new battery was used and was it properly installed.The meter is still unresponsive.Advised to seek alternate way of testing.

• Brand Name: TRUETRACK
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7616529
• Report Number: 1000113657-2018-00665
• Device Sequence Number: 11145384
• Product Code: NBW
• UDI-Device Identifier: 00096295111866
• UDI-Public: (01)00096295111866
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K032657
• 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): 06/19/2018

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 Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RV5221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1