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

Model Number	METRIX AIR
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-51 -user mechanical stress (possibly dropped, broken , mishandled) test strip udi# (b)(4).(b)(4).Customer reported symptom of feeling nervous and believes that her blood sugar is dropping.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.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for broken display.At the time of the call, the customer stated she was feeling nervous and believed that her blood glucose was dropping.Medical attention was not needed at the time of the call.Customer stated that she saw three dashes displayed across the screen.Customer was informed that the three dashes means the display of the meter is broken.
Event or Problem Description
Consumer reported complaint for broken display.At the time of the call, the customer stated she was feeling nervous and believed that her blood glucose was dropping.Medical attention was not needed at the time of the call.Customer stated that she saw three dashes displayed across the screen.Customer was informed that the three dashes means the display of the meter is broken.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # 01607751 test strips not returned for evaluation.Returned meter evaluated with defect found.On the investigation on 1/8/2019 resulted in defect found meter screen/case cracked final root cause: rc-024-the meter has a broken lcd display due to user mechanical stress.The meter is not reportable because, the meter safety trace has been activated and it will not run a blood glucose test.Test strip udi# (b)(4).Patient code 3191 (above): no code available - customer reported symptom of feeling nervous and believes that her blood suger is dropping.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.Product notification letter sent to customer to contact customer care.

• 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: 8199424
• Report Number: 1000113657-2018-01289
• Device Sequence Number: 11158787
• Product Code: NBW
• UDI-Device Identifier: 00052569139042
• UDI-Public: (01)00052569139042
• 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): 01/17/2019

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: 07/29/2019
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MV2763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 01/17/2019
• 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