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

Model Number	TRUEMETRIX
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is undergoing an evaluation but has not yet been completed.Test strip udi#: (b)(4).Note: manufacturer contacted customer on (b)(6) 2019 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for lo display.The expected fasting blood glucose test result range is 120-140mg/dl.The 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 in the den.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 5/31/2020, and open vial date is approximately 3-5 days ago.The meter memory was reviewed for previous test result history: (b)(6).Customer first called because of error messages he did not know what it was then we ran a blood and the meter reading 21mg/dl then ran the blood again and it read lo with no symptoms.Customer confirmed that he closes the lid on the strips with every use.He just opened this vial about 3-5 days ago with no problems.
Event or Problem Description
Consumer reported complaint for lo display.The expected fasting blood glucose test result range is 120-140mg/dl.The 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 in the den.During the call on 12/28/2018, a blood test was not performed by the customer.The test strip lot manufacturer's expiration date is 5/31/2020 and open vial date is approximately 3-5 days ago.The meter memory was reviewed for previous test result history: result 1: lo 12/24, 101pm, fasting; result 2:21mg/dl, 1/1 12:20pm, fasting; result 3 lo 12/28, 4:04pm, fasting; result 4:213mg/dl, 12/26 10:19pm, fasting; result 5:155mg/dl, 12/25 5:24pm, fasting; result 6:106mg/dl, 12/23 6:14pm, fasting.Customer first called because of error messages he did not know what it was then we ran a blood and the meter reading 21mg/dl then ran the blood again and it read lo with no symptoms.Customer confirmed that he closes the lid on the strips with every use.He just opened this vial about 3-5 days ago with no problems.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report #: (b)(4).Returned meter evaluated with no defect found.Returned test strips evaluated with defect found.Qc investigation on 1/15/2019 returned test strips produce lo, e-5 and low readings.R&d final root cause: most likely underlying root cause of low results are due to improper storage: vial left open for an extended period of time.Test strip udi#: (b)(4).Note: manufacturer contacted customer on 1/14/2019 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.

• 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: 8275443
• Report Number: 1000113657-2019-00063
• Device Sequence Number: 13967195
• Product Code: NBW
• UDI-Device Identifier: 00021292006082
• UDI-Public: (01)00021292006082
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/29/2019

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: MV3041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 01/29/2019
• 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