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

Model Number	TRUEMETRIX
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is undergoing an evaluation but has not yet been completed.Test strip udi# (b)(4).Note: manufacturer contacted customer on (b)(6) 2019 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for hi display.Daughter is calling on behalf of the customer.The expected fasting blood glucose test result range is 230 -240mg/dl.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.Product is stored according to specification in the bedroom.During the call on (b)(6) 2019, a blood test was performed by the customer and produced test results of 286 and 284mg/dl fasting using true metrix meter.The test strip lot manufacturer's expiration date is 06/28/2020 and open vial date is (b)(6) 2019.The meter memory was reviewed for previous test result history: (b)(6).
Additional Manufacturer Narrative
(manufacturer narrative t, corrected data f) internal report # (b)(4).Test strip udi#(b)(4).Note: manufacturer contacted customer on 2/4/2019 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for hi display.Daughter is calling on behalf of the customer.The expected fasting blood glucose test result range is 230 -240mg/dl.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.Product is stored according to specification in the bedroom.During the call on (b)(6) 2019, , a blood test was performed by the customer and produced test results of 286 and 284mg/dl fasting using true metrix meter.The test strip lot manufacturer's expiration date is 06/28/2020 and open vial date is 1/6/2019.The meter memory was reviewed for previous test result history: result 1:392mg/dl date:(b)(6) 2019, time:1106am fasting.Result 2:546mg/dl date:(b)(6) 2019, time:804pm fasting.Result 3:535mg/dl date:(b)(6) 2019, time:754pm fasting.Result 4:516mg/dl date:(b)(6) 2019, time:530pm fasting.Result 5:382mg/dl date:(b)(6) 2019, time:1122am fasting.

• 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: 8364145
• Report Number: 1000113657-2019-00152
• Device Sequence Number: 11271507
• Product Code: NBW
• UDI-Device Identifier: 00021292007041
• UDI-Public: (01)00021292007041
• Combination Product (Y/N): N
• Initial Reporter State: MI
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV3081S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY; SECOND THERAPY