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

Model Number	METRIX AIR
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Hypoglycemia (1912); Confusion/ Disorientation (2553)
Date of Event	05/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause of malfunction: mlc-20.User's test strip had poor storage (kitchen).(b)(4).Manufacturer contacted customer on (b)(6) 2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer had no symptoms and no medical attention reported at the time of the call.Customer satisfied with the replacement product.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 357 mg/dl.The customer's expected fasting blood glucose test result range is 112 to 130mg/dl.The customer did report symptoms of hypoglycemia/ disorientation.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product is not stored according to specification in the kitchen.The test strip lot manufacturer's expiration date is 05/28/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history (date / time not set): (b)(4).Customer called in states that the meter read 357mg/dl fasting and states she took 15 units of insulin and customer later began to feel symptoms of hypoglycemia.Customer did not specify if she had eaten after the administration of the insulin.Customer states she became disoriented.States she did not know where she was, she did not know who her daughter was, and did not know who she was.Customer states her daughter took her to the hospital (b)(6) 2017.Customer was admitted to the hospital for hypoglycemia.The meter at the hospital read 43mg/dl non-fasting.Customer states she received d50 when she was admitted.States her sugar kept dropping and was put on an iv saline and sugar.Customer was discharged on (b)(6) 2017.

• 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: 6602464
• Report Number: 1000113657-2017-00926
• Device Sequence Number: 739404
• Product Code: NBW
• UDI-Device Identifier: 00010939742445
• UDI-Public: (01)00010939742445
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 05/31/2017

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: MT2246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 05/31/2017
• 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