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 Code	Hypoglycemia (1912)
Date of Event	04/11/2018
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-55 user had an inaccurate reference: competitor's meter: the end user is comparing results obtained from trividia's bgm system to the results from a competitor's bgm system (b)(4).Manufacturer contacted customer on (b)(6) 2018 in a follow-up call in order 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 since the last call.
Event or Problem Description
Consumer reported complaint for low blood glucose results.The customer is concerned with results obtained of 42, 91 and 98mg/dl.Customer states that her meter is reading 40-50 points lower than the other brand.The expected fasting blood glucose test result range is 130-145mg/dl.The customer felt well at the time of the call.However the customer did report symptom of not feeling well on (b)(6) 2018 and medical attention is reported at that time as a result of low blood glucose results and reported symptoms.The product is not stored by customer according to specification in the kitchen.The test strip lot manufacturer's expiration date is 07/31/2019 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (date/time not stored correctly): result 1:91mg/dl date: (b)(6) 2018 time:8:49am fasting; result 2:144mg/dl date: (b)(6) 2018 time:11:11pm fasting; result 3:157mg/dl date: (b)(6) 2018 time:10:23pm fasting; result 4:130mg/dl date:(b)(6) 2018 time:9:39pm fasting; result 5:98mg/dl date: (b)(6) 2018 time:8:19pm fasting.Back in (b)(6) customer was feeling sick.Customer's husband told her to call an ambulance.Customer check her blood sugar with our meter and the results was 42mg/dl fasting.Customer called paramedics; they administered medication and stayed with her for an hour.They check her blood sugar again and the results was 72mg/dl non-fasting with true metrix air.Customer was not transmitted to the hospital.Customer doesn't remember the exact date.

• 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: 7462275
• Report Number: 1000113657-2018-00484
• Device Sequence Number: 1160799
• Product Code: NBW
• UDI-Device Identifier: 00041415072787
• UDI-Public: (01)00041415072787
• 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: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/25/2018

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 Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MV2778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1