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

Model Number METER, TVH SDK W/VIAL

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Products were returned and pending qc evaluation.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.Product notification letter sent to contact customer care.

Event Description

Consumer reported complaint for physical defects of strips.The expected fasting blood glucose test result range is undisclosed.The customer did not report symptoms.Medical attention is not reported as a result.The product storage location is undisclosed.During the call a back to back blood test was not performed by the customer.The test strip lot manufacturer¿s expiration date is 01/31/2021 and open vial date is undisclosed.

Manufacturer Narrative

Sections with additional information as of 19-nov-2020 h6: updated fda's method, result, and conclusion codes.H10: test strips were returned for evaluation; returned test strips were observed stuck together in a stack and with adhesive.Meter was returned for evaluation; no defect was detected.Most likely underlying root cause: rc-080: excessive adhesive on cover edge caused by slitting process - refer to capa-19-002.Rc-003: other root cause: strips stuck together is due to excessive adhesive.

• Brand Name: SIDEKICK
• Type of Device: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 10671473
• MDR Text Key: 228460470
• Report Number: 1000113657-2020-00746
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292012823
• UDI-Public: (01)00021292012823
• Combination Product (y/n): N
• PMA/PMN Number: K051147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Model Number: METER, TVH SDK W/VIAL
• Device Catalogue Number: D4H01-83
• Device Lot Number: SV5293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Distributor Facility Aware Date: 09/16/2020
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1