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

Model Number	METRIX AIR
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Headache (1880); Weakness (2145)
Date of Event	10/29/2018
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: mlc-20-user's test strip had poor storage(kitchen).(b)(4).Manufacturer contacted customer on (b)(6) 2018 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 high blood glucose results.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is 120mg/dl.The customer did report symptoms of headache and feeling weak.Medical attention is not reported as a result of the actual blood glucose results.The product is not stored by customer according to specification in the kitchen.The test strip lot manufacturer's expiration date is 04/30/2020 and open vial date is last week.The meter memory was reviewed for previous test result history: (date/time not stored correctly) result 1:236mg/dl date:(b)(6) 2018 time:10:34pm fasting; result 2:218mg/dl date: (b)(6) 2018 time:6:52pm fasting; result 3:168mg/dl date:(b)(6) 2018 time:4:46pm fasting; result 4:189mg/dl date:(b)(6) 2018 time:2:36pm fasting; result 5:218mg/dl date:(b)(6) 2018 time:12:11 pm fasting.Customer states that her meter is giving higher than normal results.Customer stated that yesterday (b)(6) 2018, she was feeling very weak and had a very bad headache.Customer stated that she took her bold glucose and it was in the 260's(unsure of actual result) and she knew felt that the meter was incorrect.Customer stated that she went to the er and when she arrived, her blood glucose was 185 mg/dl fasting.Customer stated that the hospital ran some tests (did not know what tests were run) and that she was advised that she has a virus.Diagnosis was not related to diabetes.No medications were given was just advised to give it a few days to pass.At time of call customer feel well and medical attention is not required.

• Brand Name: METRIX AIR
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 8095178
• Report Number: 1000113657-2018-01195
• Device Sequence Number: 19493092
• Product Code: NBW
• UDI-Device Identifier: 00021292007010
• UDI-Public: (01)00021292007010
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 11/21/2018

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: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MV2991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1