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	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not yet 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.Test strip (b)(4).
Event or Problem Description
Consumer reported complaint for low blood glucose results.The customer is concerned with the result of 60 mg/dl.The expected fasting blood glucose test result range is 100 to 108 mg/dl.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored by customer according to specification.The test strip lot manufacturer's expiration date is 09/14/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history.(date/time not stored correctly) (b)(6).Customer called just received this meter and strips from his dr's pharmacy and she noticed how much lower the blood results were on this meter compared to the accucheck that she has been using with much success.She said she has gone to the dr's to check out her accucheck so she knows it is running similar to the dr's blood results and this meter is coming in way too low.
Additional Manufacturer Narrative
(b)(4).Returned meter and returned test strips evaluated with no defects found.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 test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for low blood glucose results.The customer is concerned with the result of 60mg/dl.The expected fasting blood glucose test result range is 100 to 108mg/dl.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored by customer according to specification.The test strip lot manufacturer's expiration date is 09/14/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history.(date/time not stored correctly): (b)(6).Customer called just received this meter and strips from his dr's pharmacy and she noticed how much lower the blood results were on this meter compared to the accucheck that she has been using with much success.She said she has gone to the dr's to check out her accucheck so she knows it is running similar to the dr's blood results and this meter is coming in way too low.

• 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: 6843629
• Report Number: 1000113657-2017-01664
• Device Sequence Number: 656502
• Product Code: NBW
• UDI-Device Identifier: 00087701427398
• UDI-Public: (01)00087701427398
• 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: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2017

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: MU2386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 08/17/2017
• Supplement Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1