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	11/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: (b)(4) -user's test strip had poor storage (kitchen) note: manufacturer contacted customer on (b)(4) 2017 in a follow-up call in order 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 since the last call.
Event or Problem Description
Consumer initially reported complaint for dead meter; complaint was able to be resolved through troubleshooting.Customer then reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 134 mg/dl.The customer's expected fasting blood glucose test result range is 80 - 100 mg/dl.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call on (b)(6) 2017, a back to back blood test was not performed by the customer.The product is not stored according to specification and is stored in the kitchen.The test strip lot manufacturer's expiration date is 11/15/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history (date / time not set): result 1 :134mg/dl date: (b)(6) 2017 time:12:00pm fasting.Result 2 :122mg/dl date: (b)(6) 2017 time:01:10pm fasting.Result 3 : 98mg/dl date: (b)(6) 2017 time:12:14pm fasting.Result 4 :107mg/dl date: (b)(6) 2017 time:12:58am fasting.Result 5 :103mg/dl date: (b)(6) 2017 time:12:35pm fasting.Customer is calling because she states her meter is reading inaccurately.The customer first called stating that her meter was not turning on, but we were able to trouble shoot the meter and it turns on.Customer tested this morning after waking up and the meter read 134 mg/dl and it was a fasting result.Customer states her morning reading has never read that high.Customers normal glucose range is from 80-100 fasting in the morning.

• 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: 7080227
• Report Number: 1000113657-2017-02030
• Device Sequence Number: 19282374
• Product Code: NBW
• UDI-Device Identifier: 00021292007867
• UDI-Public: (01)00021292007867(17)181115(10)MU2469
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 12/04/2017

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: 11/15/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1