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

Model Number	TRUEMETRIX
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.Customer disconnected the call; unable to send replacement product and unable to make contact with her on follow-up attempts.Most likely underlying root cause: mlc-28 - there was not enough information to determine the mlurc.Test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for erratic blood glucose test results.Customer was transferred from customer care coordinator who stated that customer believes results from meter are not accurate and that customer says that she is not feeling well.Customer came on the line and stated that she had to hang up because she is not feeling well.Customer was advised to hang up and call for medical assistance.Customer then disconnected the call; no further information was able to be obtained.

• 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: 6997577
• Report Number: 1000113657-2017-01898
• Device Sequence Number: 19295664
• Product Code: NBW
• UDI-Device Identifier: 00021292007010
• UDI-Public: (01)00021292007010
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/02/2017

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: 10/24/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2444
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 11/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1