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

Model Number	TRUEMETRIX
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	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-20-user's test strip had poor storage(bathroom).Test strip udi# (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 and erratic blood glucose test results.The customer is concerned with tests results of 58 and 61mg/dl.The expected fasting blood glucose test result range is 70-80mg/dl.The customer did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is not stored according to specification in the bathroom.Test strip lot manufacturer's expiration date is 04/23/2019, and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (b)(6).
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = t) internal report (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strip udi# (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.Correction:.
Event or Problem Description
Consumer reported complaint for low and erratic blood glucose test results.The customer is concerned with tests results of 58 and 61mg/dl.The expected fasting blood glucose test result range is 70-80mg/dl.The customer did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is not stored according to specification in the bathroom.Test strip lot manufacturer's expiration date is 04/23/2019 and open vial date is 10/30/2018.The meter memory was reviewed for previous test result history: result 1:123mg/dl date:(b)(6) time:1:53pm fasting, result 2:61mg/dl date:(b)(6) time:1:51pm fasting, result 3:108mg/dl date:(b)(6) time:2:00am fasting, result 4:126mg/dl date:(b)(6) time:10:17pm unknown, result 5:58mg/dl date:(b)(6) time:1:53pm fasting.

• 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: 8181867
• Report Number: 1000113657-2018-01269
• Device Sequence Number: 16444809
• Product Code: NBW
• UDI-Device Identifier: 00041220001286
• UDI-Public: (01)00041220001286
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/14/2019

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 Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2654
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 01/14/2019
• 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