MAUDE Adverse Event Report: TRIVIDIA HEALTH INC TRUE METRIX; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number	KIT, TMX NFRS STARTER MG/DL
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter was returned - product evaluation in-process.Note: manufacturer contacted customer in several follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 384, 326, 307, 303 and 320 mg/dl.Customer stated these high results started within the past two weeks.The customer¿s expected fasting blood glucose test result range is 150-220 mg/dl.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, a blood test was performed by the customer fasting and produced test result of 271 mg/dl using the meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 01/15/2022 and open vial date is (b)(6) 2020.The meter memory was reviewed for previous test result history: (b)(6).
Additional Manufacturer Narrative
Sections with additional information as of 27-jan-2021: h3: device evaluated by the manufacturer.H6: updated fda's method, result, and conclusion codes.H10: test strips were not returned for evaluation.Meter was returned for evaluation.Product testing was performed and defect found: e-7 error code.Returned product was forwarded to r&d meter for root cause.R&d investigation has been completed and root cause selected.Root cause: rc-001: miscellaneous user induced contamination on the strip connector.

• Brand Name: TRUE METRIX
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 11100551
• Report Number: 1000113657-2020-00942
• Device Sequence Number: 11784387
• Product Code: NBW
• UDI-Device Identifier: 00021292006075
• UDI-Public: (01)00021292006075
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 01/27/2021

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: 01/15/2022
• Device Model Number: KIT, TMX NFRS STARTER MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MX4325S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Distributor Facility Aware Date: 12/08/2020
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1