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 Codes	Hypoglycemia (1912); Weakness (2145)
Date of Event	07/06/2018
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-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.(b)(4).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 they received the replacement product.Customer can due the troubleshooting at that time.They have not had any medical intervention or symptoms since the last call.Customer want us to contact them later.
Event or Problem Description
Consumer reported complaint for low blood glucose test results.Daughter is calling on behalf of the customer.The customer's expected non-fasting blood glucose test result range is 200 - 300 mg/dl; customer normally tests 1 hour after eating in the evenings.At the time of the call, the customer felt well and did not report any symptoms.Daughter stated that the night before customer had performed a blood test fasting and had obtained a result of 282 mg/dl.Daughter stated based on the result of 282 mg/dl customer had administered 8 units of insulin.When customer tested again non-fasting he had obtained blood glucose test results of 45, 40 and 33 mg/dl.Due to the low results, daughter had given him applesauce.Customer was also not coherent and had no strength.Daughter had called ems.Ems arrived and customer's blood glucose test result with their meter was 35 mg/dl non-fasting.Ems had administered sugar to the customer.Customer was concerned that his glucose should not have dropped so low so fast and was concerned with the non-fasting low results.During the call on (b)(6) 2018, a back to back blood test was not performed by the customer.The product is stored according to specification in the living room.Test strip lot manufacturer's expiration date is 04/30/2019 and open vial date is three weeks.The meter memory was reviewed for previous test result history: result 1 :171mg/dldate: (b)(6) 2018 time:732am fasting; result 2 :113mg/dldate: (b)(6) 2018 time:1043pm non- fasting; result 3 :33mg/dldate: (b)(6) 2018 time:1025pm non- fasting; result 4 :40mg/dldate: (b)(6) 2018 time10:12pm non- fasting; result 5 :45 mg/d date: (b)(6) 2018 time10:07pm non- fasting; result 6: 282mg/dl date: (b)(6) 2018 time:744pm fasting.

• 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: 7719937
• Report Number: 1000113657-2018-00797
• Device Sequence Number: 11029266
• Product Code: NBW
• UDI-Device Identifier: 00021292007584
• UDI-Public: (01)00021292007584
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K150052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/25/2018

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: MU2677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1