MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. METRIX AIR; BLOOD GLUCOSE SYSTEM

Model Number	METRIX AIR
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Lethargy (2560)
Date of Event	07/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not returned for evaluation.No replacement product needed at this time.Most likely underlying root cause: mlc-18 user has high glucose value.Test strip (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 contact the customer via telephone at call backs on 07/12/2017, 07/13/2017 and 07/14/2017.Unable to send product notification letter as no address on file for customer.
Event or Problem Description
Consumer reported complaint for e-5 error: test strip error.The e-5 error occurred after the sample has been applied.Grandmother is calling on behalf of the customer, her (b)(6) grandson.Grandmother stated she had tried to perform a blood test on the customer and had gotten the e-5 error five times.Grandmother stated she was able to perform a blood test on her other grandson and had obtained a result.At the time of the call on (b)(6) 2017, grandmother stated customer looked sleepy but that it was his nap time.The customer's expected blood glucose test result range was undisclosed.During the call on (b)(6) 2017, a back to back blood test was not performed by the customer.The product storage was undisclosed.The test strip lot manufacturer's expiration date is 04/30/2018 and open vial date was undisclosed.Customer only had one vial of test strips.The meter memory was not reviewed for previous test result history.

• 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: 6760291
• Report Number: 1000113657-2017-01504
• Device Sequence Number: 1541046
• Product Code: NBW
• UDI-Device Identifier: 00021292007010
• UDI-Public: (01)00021292007010
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/02/2017

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 Expiration Date: 04/30/2018
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MT2196
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 08/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1