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

Model Number	RELION TMA
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Returned test strips evaluated with defect found; black chemistry observed.Qc investigation on 4/12/2018 resulted in defect found: no chemistry observed on returned test strips.After qc investigation the event was determined to be reportable.Final root cause: other root cause: washed strips.Test strip udi# (b)(4).Manufacturer contacted customer (several attempts) in a follow-up call in order to ensure that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer complaint of e-0 error; test strip error.E-0 error occurred when the blood sample is absorbed.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 performed fasting during call on (b)(6) 2018 produced result of e-0 upon sample of blood being applied to strip.Storage location of product is undisclosed.Test strip lot manufacturer's expiration date is 07/22/2019 and open vial date is one week ago.

• Brand Name: RELION TMA
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7440163
• Report Number: 1000113657-2018-00441
• Device Sequence Number: 19209967
• Product Code: NBW
• UDI-Device Identifier: 00681131240154
• UDI-Public: (01)00681131240154
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K150052
• 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): 04/18/2018

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: RELION TMA
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MV2755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1