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

Model Number	TRUEMETRIX
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Weakness (2145)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi# (b)(4).Note: manufacturer contacted customer on (b)(4) 2018 in a follow-up call to ensure the customer's condition since the initial call; customer is feeling better and is not experiencing symptoms at the time of call.On (b)(6) 2018 customer was hospitalized (600mg/dl non-fasting)) for hyperglycemia where he received insulin therapy to bring his blood glucose level down.He was discharged on (b)(6) 2018.Customer did not used hospital meter while in hospital.Customer is now using a new meter.
Event or Problem Description
Consumer reported complaint for e-5 blood glucose results.Son is calling on behalf of the customer.Customer is concerned with results obtained of e-5 accompanied by symptoms.The expected fasting blood glucose test result range is undisclosed.The customer did report symptom of feeling weak.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.During the call on (b)(6) 2018, a blood test was performed by the customer and produced test results of e-5 using true metrix meter.The test strip lot manufacturer's expiration date is 07/31/2019 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.
Additional Manufacturer Narrative
Internal report # (b)(4).Returned meter and returned test strips evaluated with no defects found.Mlc-21-possible sample issue (user) test strip udi# (b)(4).Note: manufacturer contacted customer on 5/21/2018 in a follow-up call to ensure the customer's condition since the initial call; customer is feeling better and is not experiencing symptoms at the time of call.On (b)(6) 2018 customer was hospitalized (600mg/dl non-fasting)) for hyperglycemia where he received insulin therapy to bring his blood glucose level down.He was discharged on (b)(6) 2018.Customer did not used hospital meter while in hospital.Customer is now using a new meter.
Event or Problem Description
Consumer reported complaint for e-5 blood glucose results.Son is calling on behalf of the customer.Customer is concerned with results obtained of e-5 accompanied by symptoms.The expected fasting blood glucose test result range is undisclosed.The customer did report symptom of feeling weak.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.During the call on 05/18/2018, a blood test was performed by the customer and produced test results of e-5 using true metrix meter.The test strip lot manufacturer's expiration date is 07/31/2019 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.

• 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: 7595994
• Report Number: 1000113657-2018-00646
• Device Sequence Number: 1318030
• Product Code: NBW
• UDI-Device Identifier: 00041220001286
• UDI-Public: (01)00041220001286
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 06/15/2018
• 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; SECOND THERAPY
• Outcome Attributed to Adverse Event: Hospitalization