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

Model Number	METRIX AIR
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Blurred Vision (2137); Lethargy (2560)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-78- user hematocrit low.(b)(4).Note: manufacturer contacted customer on 11/7/2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer condition improved.No symptoms or medical attention reported since the original call.Customer satisfied with the replacement product.
Event or Problem Description
Consumer reported complaint for e-0 blood glucose results accompanied by symptoms.The expected fasting blood glucose test result range is 80 to160mg/dl.The customer feels well at the time of the call but did report symptoms on (b)(6) 2017.Medical attention is reported on (b)(6) 2017 as a result of the actual blood glucose results and reported symptoms.The product is stored by customer according to specification in the office.During the call on (b)(6) 2017, a back to back blood test was performed by the customer and produced test results of e-0 and e-0l using true metrix air meter.The test strip lot manufacturer's expiration date is 05/30/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: (date/time not stored correctly) result 1: 140 mg/dl date: (b)(6) 2017 time: 11:09pm fasting, result 2: 108 mg/dl date: (b)(6) 2017 time: 05:34m fasting, result 3: 120 mg/dl date: (b)(6) 2017 time: 02:01pm fasting, result 4: 136 mg/dl date: (b)(6) 2017 time: 09:27pm fasting, result 5: 111 mg/dl date: (b)(6) 2017 time: 03:18pm fasting.Customer concerned with his meter not reading because he checks his blood sugar 6 times a day and is on insulin.Customer kept getting e-0 when he tested.Customer had an insulin overdose on (b)(6) 2017 because he was feeling diabetic symptoms.Customer took the insulin because of the e-0 he was receiving on his meter.He was unable to get any readings from the glucose meter and he took too much insulin and had to have the paramedics come.They took his blood sugar and it was at 29 mg/dl.Customer was drooling, irresponsive, very poor vision, loopy, slurred speech, felt like he was in a coma.Customer had an injection and an iv.Received apple juice and peanut butter and jelly.They stayed with him for an hour until his blood sugar levels went back to normal.Arms were a little swollen because of the iv injections.Customer could not recall what his blood glucose was after the treatment.No other medical attention was required.He did not go to the hospital.

• 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: 7033292
• Report Number: 1000113657-2017-01950
• Device Sequence Number: 10792631
• Product Code: NBW
• UDI-Device Identifier: 00021292007010
• UDI-Public: (01)00021292007010
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 11/15/2017

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: MT2252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1