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	11/08/2018
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).Manufacturer contacted customer on (b)(4) 2018 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that they received the replacement product and they have not had any medical intervention or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for high and erratic blood glucose test results.The customer is concerned with tests results from results obtained of 183 and 206 mg/dl fasting and from back to back test results of 208 and 193 mg/dl non-fasting.The customer's expected fasting blood glucose test result range is 70 - 90 mg/dl; customer does not know their expected non-fasting range.Customer was using alcohol wipes.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call on (b)(6) 2018, a back to back blood test was performed by the customer non-fasting and produced test results of 197 mg/dl and 210 mg/dl using truemetrix meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 02/29/2020 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 = f) internal report # (b)(4) returned meter evaluated with no defect found.Returned test strips evaluated with defect found.Qc investigation on 11/29/2018 returned test strips produce high readings.Most likely underlying root cause of high results are due to improper storage; vial left open for an extended period of time, exposing strips to heat and moisture.Test strip udi#: (b)(4).Note: manufacturer contacted customer on 11/14/2018 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that they received the replacement product and they have not had any medical intervention or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for high and erratic blood glucose test results.The customer is concerned with tests results from results obtained of 183 and 206 mg/dl fasting and from back to back test results of 208 and 193 mg/dl non-fasting.The customer's expected fasting blood glucose test result range is 70 - 90 mg/dl; customer does not know their expected non-fasting range.Customer was using alcohol wipes.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call on 11/08/2018, a back to back blood test was performed by the customer non-fasting and produced test results of 197 mg/dl and 210 mg/dl using truemetrix meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 02/29/2020 and open vial date is 10/2018.The meter memory was reviewed for previous test result history: result 1: 183mg/dl, date:(b)(6) 2018, time:1:42pm, fasting; result 2:206mg/dl, date:(b)(6) 2018, time:12:02am, fasting; result 3:208mg/dl, date:(b)(6) 2018, time:12:52pm, non-fasting; result 4:193mg/dl, date:(b)(6) 2018, time:12:45pm, non-fasting; result 5:126mg/dl, date:(b)(6) 2018, time:12:02pm, non-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: 8119733
• Report Number: 1000113657-2018-01212
• Device Sequence Number: 13519230
• Product Code: NBW
• UDI-Device Identifier: 00050428275283
• UDI-Public: (01)00050428275283
• 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): 12/14/2018

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 Expiration Date: 02/29/2020
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 12/14/2018
• 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