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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # 01520389 product not yet returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value.(b)(4).Note: manufacturer contacted customer on 11/2/2017 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 reported complaint for e-5 and hi blood glucose results.(b)(6) mother, is calling on behalf of the customer.The customer is concerned with results obtained of hi and e-5.The expected fasting blood glucose test result range is 200 to 250mg/dl.The customer feels well and did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored by the customer according to specification in the bedroom but sometimes in her purse.During the call on (b)(6) 2017, a back to back blood test was not performed.The test strip lot manufacturer's expiration date is 11/30/2018 and open vial date was last week.The meter memory was reviewed for previous test result history: result 1 : hi mg/dl date: (b)(6) 2017 time: 6:43pm n- fasting.Result 2 : 266mg/dl date: (b)(6) 2017time: 2:07pm n-fasting.Result 3 : 407mg/dl date: (b)(6) 2017time: 1:05pm fasting.Result 4 : 338mg/dl date: (b)(6) 2017time: 12:49pm fasting.Result 5 : 194mg/dl date:(b)(6) 2017 time: 12:22 am fasting.Mother called in stating that the meter is reading e-5.After troubleshooting for e-5, results was hi.Advised caller that the blood sugar may be reading higher then 600mg/dl.Customer decline medical intervention and states that her daughter seems fine and has no symptoms.Mother states that her daughter never tests fasting.No fasting range was provided.

• 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: 7042193
• Report Number: 1000113657-2017-01969
• Device Sequence Number: 19369308
• Product Code: NBW
• UDI-Device Identifier: 00021292007911
• UDI-Public: (01)00021292007911
• 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: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

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 Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2487
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1