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	No Code Available (3191)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.Customer disconnected the call; unable to send replacement product.Most likely underlying root cause: mlc-134-user has low glucose value.(b)(4).Patient code (b)(4) (above): no code available - customer reported symptoms of glazed eyes and slurred speech.Note: manufacturer contacted customer (several attempts) in a follow-up call in order to obtain more information and replaced the product - unable to establish contact with the customer at this time.Unable to send product letter.No address on file.
Event or Problem Description
Consumer reported complaint of low blood glucose resuts with symptoms.Nurse is calling on behalf of the customer.At the time of the call the customer felt well and did not report any symptoms.Nurse stated that customer had been hospitalized on (b)(6) 2018.At that time, the customer had symptoms of glazed eyes and slurred speech.Blood glucose results obtained using the truemetrix air meter were 20 and 30 mg/dl.Nurse did not disclose if tests were performed fasting or non-fasting.Nuse refused to answer further question and disconnected call.Followed up call was made and and voicemail was left.

• 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: 7292799
• Report Number: 1000113657-2018-00227
• Device Sequence Number: 16456381
• Product Code: NBW
• UDI-Device Identifier: 00311917173894
• UDI-Public: (01)00311917173894
• 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: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2018

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: 04/30/2019
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2667
• 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: 01/31/2018
• Initial Report FDA Received Date: 02/23/2018
• 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