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

Model Number	STRIP, PUBLIX 50CT TT
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were returned - product evaluation in-process.Most likely underlying root cause is pending investigation completion.Note: manufacturer contacted customer in a follow-up call on 29-apr-2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
Event or Problem Description
Consumer reported complaint for hi blood glucose test results.Daughter is calling on behalf of the customer.Customer had only performed one blood test using the true track meter, obtained hi and is concerned with the result.Daughter stated a blood test was performed using another device (same hand/finger) and customer had obtained a result of 338 mg/dl (fasting/non-fasting status unknown).The customer¿s expected am fasting blood glucose test result is below 200 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 back to back blood test was not performed by the customer.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 07/31/2021 and open vial date is (b)(6) 2021.The meter memory was reviewed for previous test result history: result 1: hi date: 4/13 time: 10:38p unknown.
Additional Manufacturer Narrative
Sections with additional information as of (b)(6)2021: h3: was the device evaluated by the manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: meter and test strips were returned for evaluation.Product testing was performed and no defect found.Most likely underlying root cause: mlc-055: user had an inaccurate reference: competitor¿s meter: the end user is comparing results obtained from trividia¿s bgm system to the results from a competitor¿s bgm system.

• Brand Name: TRUETRACK
• 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: 11813700
• Report Number: 1000113657-2021-00312
• Device Sequence Number: 4357120
• Product Code: NBW
• UDI-Device Identifier: 00021292008642
• UDI-Public: (01)00021292008642
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K032657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: 07/31/2021
• Device Model Number: STRIP, PUBLIX 50CT TT
• Device Catalogue Number: A4H01-81
• Device Lot Number: RW5334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Distributor Facility Aware Date: 04/14/2021
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1