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	Polydipsia (2604)
Date of Event	02/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value.(b)(4).Manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for hi blood glucose results.School health aide is calling on behalf of the customer.The customer is concerned with all results obtained and hi.The expected fasting blood glucose test result range is 80-100mg/dl.The customer did report symptoms of excessive thirst.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product is not stored by customer according to specification in their possession to school.During the call on (b)(6) 2018, a back to back blood test was performed fasting by the customer and produced test results of hi using true metrix air meter.The test strip lot manufacturer's expiration date is 11/25/2018 and open vial date is unknown.The meter memory was reviewed for previous test result history: (date/time not stored correctly) result 1:himg/dl time:7:59a date:2/09 fasting, result 2:503mg/dl time:12:23p date:2/08 fasting, result 3:489mg/dl time:5:48p date:2/07 fasting, result 4:178mg/dl date:1:31p date:2/07 fasting, result 5:155mg/dl time:12:07p date:2/07 fasting, school calling in for the customer (b)(6).Caller stated that she tested fasting and result displayed e5 after blood was applied.Customer is having symptoms of hyperglycemia.Customer is extremely thirsty.The customer stated that normally when the readings are high she would test with another meter (brand unknown) and results would be high.Customer stated her doctor wants her sugar to be below 100mg/dl fasting.Upon trouble shooting, walked customer thru a test and the result displayed hi.
Event or Problem Description
Consumer reported complaint for hi blood glucose results."school" health aide is calling on behalf of the customer.The customer is concerned with all results obtained and hi.The expected fasting blood glucose test result range is 80-100mg/dl.The customer did report symptoms of excessive thirst.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product is not stored by customer according to specification in their possession to school.During the call on (b)(6) 2018, a back to back blood test was performed fasting by the customer and produced test results of hi using true metrix air meter.The test strip lot manufacturer's expiration date is 11/25/2018 and open vial date is unknown.The meter memory was reviewed for previous test result history: (date/time not stored correctly) (b)(6).School calling in for the customer 14yr old.Caller stated that she tested fasting and result displayed e5 after blood was applied.Customer is having symptoms of hyperglycemia.Customer is extremely thirsty.The customer stated that normally when the readings are high she would test with another meter (brand unknown) and results would be high.Customer stated her doctor wants her sugar to be below 100mg/dl fasting.Upon trouble shooting, walked customer thru a test and the result displayed hi.
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-18- user has high glucose value.Test strip udi# (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.

• 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: 7318661
• Report Number: 1000113657-2018-00276
• Device Sequence Number: 119708
• Product Code: NBW
• UDI-Device Identifier: 00021292007010
• UDI-Public: (01)00021292007010
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/04/2018

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: MU2483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY; SECOND THERAPY