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	10/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-20-user's test strip had poor storage (kitchen) (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 308, 282 and 206 mg/dl.The customer's expected fasting blood glucose test result range is 130 - 150 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.Customer stated that she is using alcohol pads to cleanse finger before testing; customer was advised of proper testing technique.The product is not stored according to specification and is stored in the kitchen.The test strip lot manufacturer's expiration date is 10/24/2018 and open vial date is (b)(6) 2017.Customer had another unopened bottle of test strips with a different lot number.Back to back blood test during the call on (b)(6) 2017 was performed non-fasting using this different lot number of test strips and produced test results of 224 mg/dl and 202 mg/dl using truemetrix air meter.Lot number was not provided at time of call, attempted to contact customer to obtain and voicemail was left.The meter memory was reviewed for previous test result history: result 1 : 308 mg/dl date: (b)(6) time: 10:13am fasting, result 2 : 282 mg/dl date: (b)(6) time: 8:44am fasting , result 3 : 206 mg/dl date: (b)(6) time: 7:30am fasting, result 4 : 137 mg/dl date: (b)(6) time: 4:52am fasting, result 5 : 124 mg/dl date: (b)(6) time: 2:34am fasting.

• 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: 6999753
• Report Number: 1000113657-2017-01903
• Device Sequence Number: 1299220
• Product Code: NBW
• UDI-Device Identifier: 00021292007010
• UDI-Public: (01)00021292007010
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/03/2017

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: 10/24/2018
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2444
• 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: 10/13/2017
• Initial Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1