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

Model Number	METRIX AIR
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	07/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Returned test strips evaluated with defect found.Qc investigation on (b)(6) 2018 resulted in defect found; returned test strips produce lo readings and e-5 error codes and the event was determined to be reportable.R&d final root cause : most likely underlying root cause of lo and e-5 errors are due to improper storage: vial left open for an extended period of time.(b)(4).Note: manufacturer contacted customer on (b)(6) 2018 in a follow-up call 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 or symptoms since the last call.
Event or Problem Description
Consumer reported complaint of e-3 error: used test strip, test strip outside of vial too long, sample on top of test strip.The e-3 error occurred when the blood sample was absorbed.During the call on (b)(6) 2018 the customer reported feeling shaky, but was not sure if it was due to diabetes or his parkinson's disease.Customer did not need medical attention at the time of the call.Medical intervention is not reported at the time of the call on (b)(6) 2018 as a result of the meter's readings.Blood test performed during call on (b)(6) 2018 produced result of e-3 error.The product is stored according to specification in the dining room.The test strip lot manufacturer's expiration date is 03/31/2019 and open vial date was undisclosed.Adverse event not reported at time of call.Customer requested to be called back on (b)(6) 2018 after he went to a previously scheduled doctor's appointment.At call back, customer's condition had improved and he did not currently have any diabetic symptoms.No medical intervention since the last call was reported.No additional blood tests were performed using the truemetrix air meter.

• 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: 7733037
• Report Number: 1000113657-2018-00805
• Device Sequence Number: 19468272
• Product Code: NBW
• UDI-Device Identifier: 00021292007584
• UDI-Public: (01)00021292007584
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/30/2018

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 Expiration Date: 03/31/2019
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1