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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were returned for evaluation.Product testing was performed and defect found on returned test strips: physical defects of strips - strips stuck together.No defect found on returned meter.Root cause: (b)(4): other root cause: strips stuck together due to excess of adhesive.Manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.Manufacturer acknowledges the lateness of this report and initiated the necessary corrective action.Manufacturer corrective action number: capa (b)(4).
Event or Problem Description
Consumer reported complaint for physical defect of test strips, stating that the test strips with the sidekick meter were sticking together.Customer stated that she has to separate the test strips when she tries to test.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; open vial date and product storage were not disclosed.

• 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: 13939059
• Report Number: 1000113657-2022-00177
• Device Sequence Number: 11995165
• Product Code: NBW
• UDI-Device Identifier: 00021292012823
• UDI-Public: (01)00021292012823
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 03/29/2022

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: 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Distributor Facility Aware Date: 12/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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