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

Model Number	METRIX AIR
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Codes	Lethargy (2560); Polydipsia (2604)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not returned for evaluation.Replaced test strips only.Most likely underlying root cause: mlc-25- strip inserted backwards or upside-down.Test strip udi# (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for meter not reading blood results accompanied by symptoms.Friend is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of feeling sleepy and having excessive thirst.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.Test strip lot manufacturer's expiration date is 10/13/2019 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Customer feels sleepy and has excessive thirst.Puts the strip into the meter and once the blood is absorbed it does not go into test mode.

• 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: 8142937
• Report Number: 1000113657-2018-01232
• Device Sequence Number: 1746192
• Product Code: NBW
• UDI-Device Identifier: 00052569139042
• UDI-Public: (01)00052569139042
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/07/2018

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 Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MV2855
• 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: 11/14/2018
• Initial Report FDA Received Date: 12/07/2018
• 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