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

Model Number	TRUBALANCE
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Returned meter evaluated with no defect found.Returned test strips evaluated with defect found; black chemistry observed.Qc investigation on (b)(6) 2018 resulted in defect found: returned test strips produced e-3 error codes and black chemistry observed.After qc investigation the event was determined to be reportable.Final root cause.Other root cause: black chemistry due to improper storage.Test strip (b)(4).
Event or Problem Description
Consumer complaint of e-3 error; test strip error.E-3 error occurred upon insertion of test strip into meter port.Customer feels well and observed no symptoms.Medical intervention is not reported at the time of the call on (b)(6) 2018 as a result of the meter's readings.Blood test was not performed fasting during call.Verified storage of product is not within instructed specification since they are retained in the kitchen.Test strip lot manufacturer's expiration date is 11/20/2018 and open vial date is (b)(6) 2018.

• Brand Name: TRUBALANCE
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7296364
• Report Number: 1000113657-2018-00229
• Device Sequence Number: 1847147
• Product Code: NBW
• UDI-Device Identifier: 00021292003135
• UDI-Public: (01)00021292003135
• Combination Product (Y/N): N
• Initial Reporter State: PR
• PMA/510(K) Number: K090495
• 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): 02/26/2018

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: TRUBALANCE
• Device Catalogue Number: H4H01-81
• Device Lot Number: BT4918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1