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

Model Number	TRUEMETRIX
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report: (b)(4).Meter was returned for evaluation.No defect was detected.Test strips were not 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 strips udi: (b)(4).Note: manufacturer contacted customer in a follow-up call to ensure that the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with all high test results obtained.The expected fasting blood glucose test result range is unknown.The customer did not report symptoms.Medical attention is reported as a result of the actual blood glucose results.The product is stored according to specification in the bedroom.During the call a back to back blood test was not performed by the customer.The test strip lot manufacturer's expiration date is 07/31/2020 and open vial date is july 2019.The meter memory was reviewed for previous test result history.(b)(6).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with all high test results obtained.The expected fasting blood glucose test result range is unknown.The customer did not report symptoms.Medical attention is reported as a result of the actual blood glucose results.The product is stored according to specification in the bedroom.During the call a back to back blood test was not performed by the customer.The test strip lot manufacturer's expiration date is 07/31/2020 and open vial date is july 2019.The meter memory was reviewed for previous test result history.Result 1: 317mg/dl date: (b)(6) 2019 time: 4:38pm fasting, result 2: 169mg/dl date: (b)(6) 2019 time: 12:30pm fasting , result 3: 189mg/dl date: (b)(6) 2019time: 11:25am fasting , result 4: 70mg/dl date: (b)(6) 2019 time: 7:49am fasting , result 5: 192mg/dl date:(b)(6) 2019 time: 5:29am fasting , result 6: 401mg/dl date: 7/02/2019 time: 8:15pm unknown.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) sections with additional information as of 07-may-2020: h6: updated fda's method code.H10: test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested and passed.Internal report: (b)(4).Meter was returned for evaluation.No defect was detected.Test strips were not 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 strips udi: (b)(4).Note: manufacturer contacted customer in a follow-up call to ensure that the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.

• 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: 8843117
• Report Number: 1000113657-2019-00773
• Device Sequence Number: 1618071
• Product Code: NBW
• UDI-Device Identifier: 00021292007041
• UDI-Public: (01)00021292007041
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/07/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2020
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV3142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 05/07/2020
• 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