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

Model Number	METRIX AIR
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	10/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.Customer discarded the product.Most likely underlying root cause: mlc-41 -dead battery.(b)(4).Note: manufacturer contacted customer on (b)(6) 2018 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for dead meter followed by symptoms.The expected fasting blood glucose test result range is undisclosed.Customer did report symptoms.Medical attention is reported as a result of the actual symptoms.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 06/21/2019 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Customer is well at time of initial call.Meter does not turn on at all.Battery was inserted correctly.A follow up call was made on (b)(6) 2018; while waiting on trividia meter to arrive, customer states her glucose dropped on (b)(6) 2018.Customer was experiencing symptoms and called the paramedics.Customer states the paramedics arrived and her blood glucose was 32mg/dl fasting.The paramedics administered glucose iv.Customer is stable now and states she will discard her old meter.Customer states she felt her normal symptoms (not specified) of low glucose and decided to call paramedics.Customer had no symptoms at time of call and does not require and medical attention at this time.

• 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: 8056342
• Report Number: 1000113657-2018-01151
• Device Sequence Number: 13899982
• Product Code: NBW
• UDI-Device Identifier: 00021292007584
• UDI-Public: (01)00021292007584
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 11/09/2018

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 Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MV2721
• 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: 10/17/2018
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1