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

Model Number	METRIX AIR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	02/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-20-user's test strip had poor storage (kitchen).Test strip udi# (b)(4).Note: 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 no known device problem.The customer is concerned with results obtained being inaccurate.The expected fasting blood glucose test result range is 100 to 146mg/dl.The customer did report symptoms of being unconscious on a previous event.Customer had no symptoms at the time of the call.Medical attention is reported as a result of the previous 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 10/18/2017 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: result 1 :233mg/dl date:(b)(6) 2018 time:04:30pm non-fasting, result 2 :203mg/dl date:(b)(6) 2018 time:01:13pm non-fasting, result 3 :384mg/dl date:(b)(6) 2018 time:12:13pm fasting, result 4 :283mg/dl date:(b)(6) 2018 time:09:07am fasting, result 5 :306mg/dl date:(b)(6) 2018 time:05:41am fasting.Customer is not concerned with these results because her insulin pump is broken.Customer is not happy with this meter at all because she feels it is just inaccurate.Customer called saying her blood sugar is not being read accurately on this meter.Customer first called to complain about an e-3 error, walked customer through how to correctly work the meter and run a blood test and customer got a result of 244mg/dl non-fasting.Customer was not testing properly; she was holding the meter horizontal at times.Customer is aware that her blood sugar should be reading higher now because her insulin pump is broken.Customer is concerned that all the readings are inaccurate because she is comparing the meter to her cgm.Asked customer to verify which readings in her meters memory she was concerned with, but she could not pinpoint a particular reading.Past event: customer had an episode of low blood sugar.Customer was unconscious and so the paramedics were called.Paramedics read her blood sugar as 26mg/dl.Paramedics gave her a dextrose iv in the ambulance.When customer was conscious, she said she refused to go to the er and she stayed home.Customer does not recall date of event or what her blood sugar was when the paramedics went away, but she felt better.

• 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: 7344824
• Report Number: 1000113657-2018-00314
• Device Sequence Number: 11197786
• Product Code: NBW
• UDI-Device Identifier: 00021292007010
• UDI-Public: (01)00021292007010
• 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): 03/16/2018

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: MU2433
• 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: 02/20/2018
• Initial Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1