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 Code	Hypoglycemia (1912)
Date of Event	11/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet 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).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for high blood glucose results.(b)(6), is calling on behalf of the customer.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is 160 to 180mg/dl.The customer feels well and did not report symptoms.Medical attention is reported as a result of the actual blood glucose results.The product is stored by customer according to specification in the bedroom.The test strip lot manufacturer's expiration date is 01/13/2017 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: result 1 :249mg/dl date:(b)(6) 2017 time:12:57am fasting, result 2 :261mg/dl date:(b)(6) 2017 time:12:56am fasting, result 3 :370mg/dl date:(b)(6) 2017 time:05:23pm fasting, result 4 :292mg/dl date:(b)(6) 2017 time:05:22pm fasting, result 5 :210mg/dl date:(b)(6) 2017 time:10:02pm fasting.Customer called in states the meter is reading erratic and customer is concerned that the results are high.Customer stated his wife was given a true metrix meter from insurance company.Customer stated that the meter was reading erratic back to back results.Customer stated, due to result from meter he took his wife to the hospital on (b)(6) 2017.There, her blood sugar was lower than what the true metrix meter stated.Her blood glucose reading was 90mg/dl fasting and was diagnosed with hypoglycemia.Customer treatment at the hospital was a cup of orange juice and monitoring for 2 hours.She left the hospital the same day.The insurance company replaced the meter.Customer attempted to test with the new true metrix meter and readings were still erratic and high.Customer denies the need for medical attention at the time of call and denies signs and symptoms of hyperglycemia at the time of call.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # (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.Test strip udi# (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for high blood glucose results.(b)(6), is calling on behalf of the customer.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is 160 to 180mg/dl.The customer feels well and did not report symptoms.Medical attention is reported as a result of the actual blood glucose results.The product is stored by customer according to specification in the bedroom.The test strip lot manufacturer's expiration date is 01/13/2017 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: result 1 :249mg/dl date: (b)(6) 2017 time:12:57am fasting; result 2 :261mg/dl date: (b)(6) 2017 time:12:56am fasting; result 3 :370mg/dl date: (b)(6) 2017 time:05:23pm fasting; result 4 :292mg/dl date: (b)(6) 2017 time:05:22pm fasting; result 5 :210mg/dl date: (b)(6) 2017 time:10:02pm fasting.Customer called in states the meter is reading erratic and customer is concerned that the results are high.Customer stated his wife was given a true metrix meter from insurance company.Customer stated that the meter was reading erratic back to back results.Customer stated, due to result from meter he took his wife to the hospital on (b)(6) 2017.There, her blood sugar was lower than what the true metrix meter stated.Her blood glucose reading was 90mg/dl fasting and was diagnosed with hypoglycemia.Customer treatment at the hospital was a cup of orange juice and monitoring for 2 hours.She left the hospital the same day.The insurance company replaced the meter.Customer attempted to test with the new true metrix meter and readings were still erratic and high.Customer denies the need for medical attention at the time of call and denies signs and symptoms of hyperglycemia at the time of call.

• 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: 7082843
• Report Number: 1000113657-2017-02031
• Device Sequence Number: 13648863
• Product Code: NBW
• UDI-Device Identifier: 00011822590051
• UDI-Public: (01)00011822590051
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 12/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1