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

Model Number	TRUETRACK
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Test strips not returned for evaluation.Returned meter evaluated with defect found.On the investigation on 5/30/2018 resulted in defect found.Meter displays partial characters.Based on the result the event was determined to be reportable.Final root cause : meter displays partial characters 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 - unable to establish contact with the customer at this time.Message left to contact customer care department.
Event or Problem Description
Consumer complaint of defective lcd.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.Storage of product location is undisclosed.Test strip lot manufacturer's expiration date is 08/13/2019 and open vial date is undisclosed.Customer states that the middle digit is illegible, it is not clear and cannot read it.Caller states the first and third digit are legible.No medication was administered due to the glucose reading.No adverse event reported.

• 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: 7591215
• Report Number: 1000113657-2018-00641
• Device Sequence Number: 1698851
• Product Code: NBW
• UDI-Device Identifier: 00021292001018
• UDI-Public: (01)00021292001018
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/12/2018

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: RU5088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1