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	Fatigue (1849)
Date of Event	12/19/2018
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-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strip udi# (b)(4).Note: at urgent call back on (b)(6) 2018, the customer's condition had improved and she did not currently have any diabetic symptoms.No medical attention since the last call was reported.
Event or Problem Description
Consumer initially reported complaint for e-3 error: used test strip, test strip outside of vial too long, sample on top of test strip.The customer's test strips were expired: lot # mt2239, manufacturer's expiration date of 05/22/2018.Customer did not have another vial and was going to purchase.At the time of the call, the customer reported feeling slightly tired and stated it was due to her blood sugar.Medical attention was not needed at the time of the call on (b)(6) 2018.Customer reported a past adverse event stating she had taken a medication that seemed to have lowered her blood glucose and that she does not remember what happened and was taken to the hospital.Spoke with customer's granddaughter to obtain further details.On (b)(6) 2018, customer was unconscious and unresponsive, had been snoring very loudly and drooling.911 had been called.The customer's blood glucose test result with the paramedic's meter was 46 mg/dl fasting.The customer was taken to the hospital; the diagnosis was hypoglycemia.The customer and granddaughter did not know what treatment was received.The customer was discharged at 5:00 am on (b)(6) 2018.No new medications or healthcare program had been suggested.Contacted customer on (b)(6) 2018, and customer had purchased new vial of test strips and reported complaint for low blood glucose test results.The customer is concerned with tests results from results obtained of 38 mg/dl.The customer's expected fasting blood glucose test result range is 90 - 120 mg/dl.The customer had still felt physically tired and stated she had a cold.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 135 mg/dl and 136 mg/dl using truemetrix air meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 10/31/2019 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (b)(6).Customer called in states the meter is reading low.Customer states the meter read 38mg/dl fasting.Customer states their normal fasting range is 90-120mg/dl fasting.Customer states she feels physically tired at the time of call.Customer also states she has a cold.

• 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: 8241957
• Report Number: 1000113657-2019-00030
• Device Sequence Number: 11158804
• Product Code: NBW
• UDI-Device Identifier: 00021292007911
• UDI-Public: (01)00021292007911
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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): 01/11/2019

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: 10/31/2019
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MV2881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1