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	10/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause : mlc-55 user had an inaccurate reference: competitor's meter: the end user is comparing results obtained from trividia's bgm system to the results from a competitor's bgm system.(b)(4).Manufacturer contacted customer several times 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 properly and they have not had any medical intervention since the last call.
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with meter to meter comparison and all of the results obtained.The expected fasting blood glucose test result range is 150mg/dl.The customer feels well did not report symptoms of symptom.Medical attention is reported as a result of the actual blood glucose results.The product is stored by customer according to specification in the bedroom.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 8/23/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history.(date/time not stored correctly): result 1 : 273 mg/dl date: (b)(6) 2017 time: 8 am fasting, result 2 : 211 mg/dl date: (b)(6) 2017 time: 12 pm (non), result 3 : 269 mg/dl date: (b)(6) 2017 time: 6 pm (non), result 4 : 315 mg/dl date: (b)(6) 2017 time: 10 pm (non), result 5 : 289 mg/dl date: (b)(6) 2017 time: 8 am (fasting).The customer is not having any diabetic symptoms.The diagnosis at the hospital was diabetic ketoacidosis (not due to the use of the meter).At the hospital, the customer received regular protocol for treatment for dka.Was advised to continue seeing her physician and endocrinologist to get blood glucose better control.In (b)(6), she went to the er because my blood sugar was over 500.Before i walked into the er i took my blood sugar with my true metrix glucometer and the reading was 530mg/dl fasting and then 5 minutes later they checked my blood sugar in the er triage and it was 440mg/dl fasting.So there was quite a bit of discrepancy.Thought it was a fluke.Then i went to er in (b)(6) because my blood sugar was high and again i checked my blood sugar before i walked into the er and it was 565 and when the er triage took my blood sugar 5 minutes later it was 90 to 100 point difference.The hospital tells me their glucometers are calibrated daily.I have had a difficult time getting my blood sugar under control (trying to learn everything) so i need a glucometer that is as accurate as possible.

• 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: 6985058
• Report Number: 1000113657-2017-01874
• Device Sequence Number: 1227740
• Product Code: NBW
• UDI-Device Identifier: 00011822590051
• UDI-Public: (01)00011822590051
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/27/2017

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: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1