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

Model Number	METRIX AIR
Medical Device Problem Codes	Failure to Power Up (1476); Unable to Obtain Readings (1516)
Health Effect - Clinical Codes	Hypoglycemia (1912); Dizziness (2194)
Date of Event	11/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-41 -dead battery test strip udi# (b)(4).Note: manufacturer contacted customer on (b)(4) 2018, in a follow-up call to ensure the customer's condition since the initial call; (customer's condition has improved, and they are no longer experiencing symptoms.Customer went to her doctor (routine visit for flu shoot).Customer had her blood sugar taken and their meter read 32mg/dl fasting, so they gave her candy.Customer was diagnoses with hypoglycemia.Customer was treated with candy and released the same day.
Event or Problem Description
Consumer reported complaint for dead meter accompanied by symptoms.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of feeling lightheaded.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.During the call on (b)(6) 2018, a back-to-back blood test was not performed.The test strip lot manufacturer's expiration date is 02/29/2020 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Customer is feeling light headed and feels as if sugar may be low.After troubleshooting meter still does not turn on.Customer has a routine doctor's appointment tomorrow.

• 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: 8117378
• Report Number: 1000113657-2018-01211
• Device Sequence Number: 1770389
• Product Code: NBW
• UDI-Device Identifier: 00010939742445
• UDI-Public: (01)00010939742445
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 11/29/2018

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: MV2910
• 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: 11/07/2018
• Initial Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1