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 Codes	Urinary Frequency / Polyuria (2275); Polydipsia (2604)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause: mlc-18 - user has high glucose value test strip udi# (b)(4).Note: at call back on 12/07/2018 the customer's condition had improved and she did not currently have any diabetic symptoms.Customer stated she had gone to her doctor's office on (b)(6) 2018 and that the doctor had advised her to take her "novalog".Customer took 40 units of novalog and her blood sugar had come down.Customer used the truemetrix air meter to perform additional blood tests.
Event or Problem Description
Consumer reported complaint for hi blood glucose test results.The customer is concerned with tests results of hi.The customer's expected fasting blood glucose test result is 145 mg/dl.Customer stated that she had a meal last evening that she should not have eaten.At the time of the call, the customer reported symptoms of increased thirst and frequent urination but denied the need for medical attention at the time.During the call on (b)(6) 2018, a back to back blood test was performed by the customer non-fasting and produced test results of hi and hi using truemetrix air meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 03/31/2019 and open vial date is a few weeks.The meter memory was reviewed for previous test result history: (b)(6).Customer is concerned with the hi results that she is getting from her meter.Customer has not had any changes to her medication, lifestyle, medication or diet routine.Customer states that she does try to exercise a little every day.Customer also stated that she had a meal last evening that she should not have eaten.Customer is currently having increased thirst and frequent urination but denies the need for medical attention at this time.

• 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: 8196328
• Report Number: 1000113657-2018-01280
• Device Sequence Number: 13860641
• Product Code: NBW
• UDI-Device Identifier: 00021292007911
• UDI-Public: (01)00021292007911
• 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: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/26/2018

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 Expiration Date: 03/31/2019
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1