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

Model Number	METRIX AIR
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # 01509512.Product not yet returned for evaluation.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).
Event or Problem Description
Consumer reported complaint for low blood glucose test results.Wife is calling on behalf of the customer.The customer is concerned with test results from results obtained of 66 mg/dl using truemetrix air meter and 157 mg/dl using another device.Wife stated they then stopped using the meter after.The customer's expected fasting blood glucose test result range is 128 - 132 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 stored according to specification.The test strip lot manufacturer's expiration date is 11/30/2018 and open vial date at time of call is one week.The meter memory was reviewed for previous test result history: 1:66mg/dl (b)(6) 2017 12:32 pm fasting:yes.2:68mg/dl (b)(6) 2017 12:30 pm fasting:no.3:86mg/dl (b)(6) 2017 06:16 am fasting:yes.4:65mg/dl (b)(6) 2017 07:41 pm fasting:no.5:80mg/dl (b)(6) 2017 06:54 am fasting:yes.All the blood results accessed in the memory are running on the low side.Wife said her husband does not run that low.Wife does her husband's blood in the morning as a fasting an then at bedtime.Will run the blood during the day as needed.

• 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: 6900670
• Report Number: 1000113657-2017-01756
• Device Sequence Number: 634045
• Product Code: NBW
• UDI-Device Identifier: 00041415072787
• UDI-Public: (01)00041415072787
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/28/2017

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: 11/30/2018
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2493
• 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: 09/05/2017
• Initial Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1