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

Model Number	METRIX AIR
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not 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.(b)(4).Manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - 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 erratic blood glucose results.Mother is calling on behalf of the customer.The customer is concerned with results obtained of 283 and 245mg/dl.The expected fasting blood glucose test result range is 170 to 200mg/dl.The customer feels well and 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 in the room at facility.During the call on (b)(6) 2018, a back to back blood test was not performed.Test strip lot manufacturer's expiration date is 3/31/2020 and open vial date is a few days ago.The meter memory was reviewed for previous test result history: (date/time not stored correctly) result 1:283mg/dl (b)(6) 11:36am fasting; result 2:245mg/dl (b)(6) 11:45pm fasting; result 3:177mg/dl (b)(6) 7:34pm fasting; result 4:361mg/dl (b)(6) 5:08pm fasting; result 5:271mg/dl (b)(6) 2:59pm fasting; result 6 247mg/dl (b)(6) 10:31am fasting.Customer was diagnosed with type 1 diabetes and have been having a hard time with getting his under control.He was at the hospital but now to get him under control he has been moved to (b)(6).He is currently still at (b)(6).The mother who did not know where to call about this meter and strips.Her son and the mother are at (b)(6) till they can get his type 1 diabetes under control.He is using alcohol on his fingers for every stick since this is what was recommended for him to use.They bought another meter when he would get such erratic results and was comparing it to another meter and someone also had another meter and the 2 meters would be very close but not the true metrix meter.The back to back readings were done incorrectly, just squeezing another drop and if they would do it a third time he would stick his finger staying on the same hand but always using the alcohol wipes prior to sticking himself.The time is not correct on the meter.He does his blood always before a meal or if he is having symptoms then it is done whenever he is having symptoms to check his blood.

• 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: 8102882
• Report Number: 1000113657-2018-01199
• Device Sequence Number: 13717679
• Product Code: NBW
• UDI-Device Identifier: 00681131240154
• UDI-Public: (01)00681131240154
• 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): 11/26/2018

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: MV2945S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1