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

Model Number	TRUEMETRIX
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Returned test strips evaluated with defect found; no chemistry observed.Qc investigation on 7/28/2017 resulted in defect found and the event was determined to be reportable.Final root cause investigation has been completed washed strips.No chemistry observed.No further investigation required.Test strip udi# ((b)(4).
Event or Problem Description
Consumer reported complaint of dead meter.Customer would insert a test strip and the meter would not turn on.The meter is three months old and the battery has not been replaced.Customer stated that she did not see a low battery symbol.The meter did not turn on by inserting a test strip.The meter turned on by manually pressing the white dot button.During the call on (b)(6)2017 the customer felt well and did not report any symptoms.Medical intervention is not reported at the time of the call on (b)(6)2017 as a result of the meter's readings.A blood test was not performed by the customer during the call on (b)(6)2017.The product storage was undisclosed.The test strip lot manufacturer's expiration date is 08/31/2018 and open vial date at time of call was about a month.Adverse event not reported at time of call on (b)(6)2017.

• Brand Name: TRUEMETRIX
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 6791291
• Report Number: 1000113657-2017-01550
• Device Sequence Number: 1722843
• Product Code: NBW
• UDI-Device Identifier: 00096295126655
• UDI-Public: (01)00096295126655
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K140100
• 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): 08/14/2017

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: 08/31/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 08/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1