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

Model Number	METRIX AIR
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Codes	Dizziness (2194); Urinary Frequency / Polyuria (2275)
Date of Event	04/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time most likely underlying root cause of malfunction: strip inserted backwards or upside-down (b)(4).Note: at follow-up call on (b)(6) 2017, the customer stated her condition had improved and she did not currently have any diabetic symptoms.The customer stated she had gone to see her primary physician on (b)(6) 2017 and had an mri or scan (customer was not sure which she had done) due to her dizziness.Customer stated the results would be back next week.The customer stated her blood glucose result while at her primary physician's was 201 mg/dl.Customer stated there were additional blood tests performed with the truemetrix air meter and that she was satisfied with the meter and the results obtained.Unable to contact the customer at call backs on (b)(6) 2017.Unable to send product notification letter as no address on file for customer.
Event or Problem Description
Consumer reported complaint for dead meter.The customer's expected blood glucose test result range was undisclosed.During the call on (b)(6) 2017, the customer reported feeling dizzy and having frequent urination.During the call on (b)(6) 2017, the meter came on when a test strip was inserted and by manually pressing the button on top of the meter.The battery was installed properly in the meter.The test strip was inserted in the meter correctly and the customer was using the correct brand of test strips.The test strip lot manufacturer's expiration date is 04/30/2018 and open vial date was undisclosed.The product storage was undisclosed.

• 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: 6560213
• Report Number: 1000113657-2017-00819
• Device Sequence Number: 616808
• Product Code: NBW
• UDI-Device Identifier: 00041220009169
• UDI-Public: (01)00041220009169
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2017

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: 04/30/2018
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MT2203
• 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: 04/16/2017
• Initial Report FDA Received Date: 05/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY