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

Model Number STRIP, SUNMARK (RETAIL)100CT TT

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Pending packaging investigation.

Event Description

Consumer reported complaint for missing package item(s).Customer stated that they had purchased a 100 count vial of test strips from ebay and there was no code chip included in the box with the test strips.The customer feels well and did not report any symptoms.Customer did not report that medical attention had been required at an earlier time.Customer was informed to not utilize test strips and replacement product was sent to customer.

Manufacturer Narrative

Sections with additional information as of 20-mar-2020: h6: updated fda's method, result, and conclusion codes.H10: meter was not returned for evaluation.Test strips were not returned for evaluation.Returned product was forwarded to packaging based on complaint's description.Internal evaluation has been completed, report and no abnormalities observed.

• Brand Name: TRUETRACK
• 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: 9553834
• MDR Text Key: 219168115
• Report Number: 1000113657-2020-00003
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K032657
• 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: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/26/2020
• Device Model Number: STRIP, SUNMARK (RETAIL)100CT TT
• Device Catalogue Number: A4H01-81
• Device Lot Number: RV5251
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/09/2019
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1