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 Codes	Nausea (1970); Weakness (2145)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Returned test strips evaluated with defect found.Qc investigation on 10/19/2017 returned test strips produce high readings.Most likely underlying root cause of high readings are due to improper storage: strips left outside of vial for an extended period of time test strip udi# (b)(4).Note: manufacturer contacted customer on (b)(4) /2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer's condition improved and they no longer have any diabetic symptoms.On (b)(6) 2017, the customer's wife drove him to the hospital where he was diagnosed with hyperglycemia (500mg/dl non- fasting).He was treated with iv fluids and they suggested that he followed up with his doctor.He was later discharged on (b)(6) 2017.Customer is satisfied with the replacement product.
Event or Problem Description
Consumer reported complaint for high blood glucose results accompanied by symptoms.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is 200-220mg/dl.The customer did report symptoms of nauseous, weak and tired.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product is not stored by customer according to specification in the kitchen.The test strip lot manufacturer's expiration date is 12/22/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: result 1: 234mg/dl date: (b)(6) 2017 time: 5:40pm fasting.Result 2: 262 mg/dl date: (b)(6) 2017time: 5:37pm fasting.Result 3: 290 mg/dl date: (b)(6) 2017 time: 5:36pm fasting.Result 4: 226 mg/dl date: (b)(6) 2017 time: 11:52am fasting.Result 5: 277 mg/dl date: (b)(6) 2017time: 7:09 am fasting.Customer states that him and his wife changed his diet but meter keeps reading higher than expected.Concerned with all of the results.

• 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: 6991768
• Report Number: 1000113657-2017-01883
• Device Sequence Number: 497424
• Product Code: NBW
• UDI-Device Identifier: 00725439988933
• UDI-Public: (01)00725439988933
• 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): 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1