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

Model Number	STRIP, LEADER TT MEDIMEDI 50CT
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on 13-aug-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 high and low blood glucose test results.The customer is concerned with test results from results obtained of 258, 173, 73, 182 and 191mg/dl.The customer¿s expected fasting blood glucose test result range is 80-160mg/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 not stored according to specification (kitchen).The test strip lot manufacturer¿s expiration date is 02/22/2023 and open vial date was not disclosed.The customer did not have another vial of test strips that had been stored and handled correctly.The meter memory was reviewed for previous test result history: (b)(6).
Additional Manufacturer Narrative
Sections with additional information as of 02-nov-2021: h6: updated fda¿s type, findings and conclusions codes.H10: meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: mlc-020: user's test strip had poor storage.

• 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: 12380732
• Report Number: 1000113657-2021-00516
• Device Sequence Number: 17169985
• Product Code: NBW
• UDI-Device Identifier: 00021292008642
• UDI-Public: (01)00021292008642
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Report Date (Section B): 11/02/2021

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: 02/22/2023
• Device Model Number: STRIP, LEADER TT MEDIMEDI 50CT
• Device Catalogue Number: A4H01-81
• Device Lot Number: RX5423S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/02/2021
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1