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	Low Test Results (2458)
Health Effect - Clinical Code	Presyncope (4410)
Date of Event	08/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Adverse event report is being submitted due to symptoms related to diabetes: lightheaded.Meter and test strips were returned - product evaluation in-process.Note: manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved and that the replacement products resolved the initial concern - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for low blood glucose test results.The customer is concerned with test results from results obtained of 77 and 84 mg/dl fasting.The customer does not know their expected blood glucose test result range.At the time of the call the customer reported feeling lightheaded; medical attention was not needed at the time.During the call, a blood test was performed by the customer non-fasting and produced test result of 92 mg/dl using sidekick meter.The product is stored according to specification in the dining room.The test strip lot manufacturer¿s expiration date is 10/31/2023 and open vial date is (b)(6) 2022.The meter memory was not reviewed for previous test result history; customer did provide date/time for the results of concern: result: 77 mg/dl ; date: (b)(6) 2022 ; time: 9:22 am fasting.Result : 84 mg/dl ; date: (b)(6) 2022 ; time: 9:40 am fasting.
Additional Manufacturer Narrative
Sections with additional information as of 07-oct-2022: 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 defect found on returned meter and test strips: e-7 and low results.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Root cause: rc-001: miscellaneous user induced contamination on the strip connector.

• 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
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 15392224
• Report Number: 1000113657-2022-00482
• Device Sequence Number: 6102502
• Product Code: NBW
• UDI-Device Identifier: 00021292012823
• UDI-Public: (01)00021292012823
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Model Number: METER, TVH SDK W/VIAL
• Device Catalogue Number: D4H01-81
• Device Lot Number: SY5482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/16/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 10/07/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown