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

Model Number	TRUEMETRIX
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Note: 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.
Event or Problem Description
Consumer reported complaint for low control results.The customer is concerned with tests results from results obtained of 8mg/dl.Customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored according to specification.During the call on (b)(6) 2018, a blood test was not performed by the customer.The test strip lot manufacturer's expiration date is (b)(6) 2019 and open vial date is (b)(6) 2018.The meter memory was not reviewed for previous test result history.Customer just opened his control and ran the control test with me and the results were 8mg/dl.He said he previously ran it several more times each time it was very low and that is why he is calling.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = t) internal report (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-62-user had poor technique.Test strip (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.Correct statement on section.Product was received and investigated.
Event or Problem Description
Consumer reported complaint for low control results.The customer is concerned with tests results from results obtained of 8mg/dl.Customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored according to specification.During the call on (b)(6) 2018, a blood test was not performed by the customer.The test strip lot manufacturer's expiration date is 6/15/2019 and open vial date is nov.2018.The meter memory was not reviewed for previous test result history.Customer just opened his control and ran the control test with me and the results were 8mg/dl.He said he previously ran it several more times each time it was very low and that is why he is calling.

• Brand Name: TRUEMETRIX
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 8161815
• Report Number: 1000113657-2018-01245
• Device Sequence Number: 1606424
• Product Code: NBW
• UDI-Device Identifier: 00021292006068
• UDI-Public: (01)00021292006068
• Combination Product (Y/N): N
• Initial Reporter State: IL
• PMA/510(K) Number: K140100
• 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): 12/13/2018

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: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 12/13/2018
• 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