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

Model Number	METER, TVH SDK W/VIAL
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/25/2021
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-jul-2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated the replacement products had not yet been received.Customer stated that she had a scheduled hospital procedure unrelated to her diabetes and was going to return home next week.Customer stated she would call to inform if replacement products had been received.Note: manufacturer contacted customer in a follow-up call on 20-jul-2021 to ensure the replacement products resolved the initial concern - customer answered the call but she stated that she will call back to run a control test.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 299mg/dl.Customer also stated results obtained using the sidekick meter were higher when compared to another device; actual meter to meter comparison results were not provided.The customer¿s expected evening fasting blood glucose test result range is 101-110mg/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 test strip lot manufacturer¿s expiration date is 06/22/2023 and storage location and open vial date are unknown.Customer had purchased the products from an online distributor.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 05-oct-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-062: user had poor technique.

• Brand Name: SIDEKICK
• 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: 12215066
• Report Number: 1000113657-2021-00443
• Device Sequence Number: 4066834
• Product Code: NBW
• UDI-Device Identifier: 00021292012823
• UDI-Public: (01)00021292012823
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051147
• 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): 10/05/2021

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: 06/22/2023
• Device Model Number: METER, TVH SDK W/VIAL
• Device Catalogue Number: D4H01-81
• Device Lot Number: SX5454
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/25/2021
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1