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

Model Number	METRIX AIR
Medical Device Problem Codes	Unable to Obtain Readings (1516); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperglycemia (1905); Blurred Vision (2137); Loss of consciousness (2418)
Date of Event	07/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not returned for evaluation.Customer declined replacement product at this time.Complaint resolved by training during the time of the call.Product is working as designed.Most likely underlying root cause: mlc-62 - user had poor technique.Test strip (b)(4).
Event or Problem Description
Consumer reported complaint for e-3 error code.Daughter is calling on behalf of the customer.The e-3 error occurred when the blood sample was absorbed.The customer was using improper testing technique.During the call on (b)(6) 2018, a blood test was performed by the customer non-fasting and produced test result of 334 mg/dl non-fasting.At the time of the call, the customer felt well and did not report any symptoms.Daughter stated that customer was hospitalized from (b)(6) 2018.Customer had gotten into an argument with a family member and shortly after customer had blurry vision and had fainted.The customer's blood glucose test result when at the hospital was 441 mg/dl fasting.The diagnosis was hyperglycemia and hypertension and customer had insulin administered every hour.New medication, insulin, had been suggested by healthcare professional.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 09/15/2019 and open vial date is 07/12/2018.The meter memory was not reviewed for previous test result history.

• 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: 7762420
• Report Number: 1000113657-2018-00840
• Device Sequence Number: 11070329
• Product Code: NBW
• UDI-Device Identifier: 00052569139042
• UDI-Public: (01)00052569139042
• 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: other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/08/2018

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: 09/15/2019
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MV2819
• 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: 07/13/2018
• Initial Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization