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

Model Number	STRIP, WALGREENS 50CT TT#673239
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Test strips were not returned for evaluation.Meter was returned - product evaluation in-process.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2022 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 high and erratic blood glucose test results.The customer is concerned with test results from back to back blood tests of 260, 180 and 290mg/dl am fasting.The customer was not using the proper testing technique.The customer¿s expected am fasting blood glucose test result range is 100-110mg/dl and expected pm fasting blood glucose test result range is 170-180mg/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 05/19/2023 and open vial date is one week prior to call.The meter memory was not reviewed for previous test result history.
Additional Manufacturer Narrative
Sections with additional information as of 07-jun-2022: h3: was the device evaluated by the manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: test strips were not returned for evaluation.Meter was returned for evaluation.Product testing was performed and no defect found.Most likely underlying root cause: mlc-062: user had poor technique.
Additional Manufacturer Narrative
Sections with additional information as of 26-apr-2022: h6: updated fda¿s type, findings and conclusions codes.H10: test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.

• 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
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 13550459
• Report Number: 1000113657-2022-00085
• Device Sequence Number: 17370441
• Product Code: NBW
• UDI-Device Identifier: 00021292008642
• UDI-Public: (01)00021292008642
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2022

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: 05/19/2023
• Device Model Number: STRIP, WALGREENS 50CT TT#673239
• Device Catalogue Number: A4H01-81
• Device Lot Number: RX5445S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/19/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 03/31/2022; 05/10/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 04/26/2022; 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown