MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TMETRIX PR; BLOOD GLUCOSE SYSTEM

Model Number	TMETRIX PR
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	04/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (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 high readings on level 35 and 75 and the event was determined to be reportable.Reported defect not reproduced with returned meter and test strip.Most likely underlying root cause of high control results are due to improper storage: vial left open for an extended period of time.Test strip (b)(4).Note: manufacturer cntacted 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 of e-3 error: used test strip, test strip outside of vial too long, sample on top of test strip.Wife is calling on behalf of the customer.The e-3 error occurred after the blood sample was applied.During the call on (b)(6) 2018, the customer felt well and did not report any symptoms.Medical intervention is not reported at the time of the call on (b)(6) 2018 as a result of the meter's readings.During the call on (b)(6) 2018, a blood test was not performed as customer was not at home at the time.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 07/19/2018 and open vial date is undisclosed.Adverse event not reported at time of call on (b)(6) 2018.

• Brand Name: TMETRIX PR
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7616074
• Report Number: 1000113657-2018-00664
• Device Sequence Number: 1382931
• Product Code: NBW
• UDI-Device Identifier: 00021292006105
• UDI-Public: (01)00021292006105
• Combination Product (Y/N): N
• Initial Reporter State: OH
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/19/2018

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: 07/19/2018
• Device Model Number: TMETRIX PR
• Device Catalogue Number: RE4H01P-43
• Device Lot Number: MU2326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1