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

Model Number STRIP, CVS 25CT TT

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Products were not returned for evaluation.Most likely underlying root cause: mlc-9: user error caused or contributed to event.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.

Event Description

Consumer reported complaint for missing package items.Customer stated that when she opened the truetrack kit, the vial of test strips only contained eight (two were missing) and that the code chip was also missing.Customer states that the package was sealed and not opened and that it did not look tampered with.The customer feels well and did not report any symptoms.No medical attention was required at an earlier time.

Manufacturer Narrative

Sections with additional information as of 11-apr-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 and no abnormalities observed.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.Note: customer returned a cut off piece (kit box) with lot and serial # information.No thi products were returned to manufacturer.

Manufacturer Narrative

Sections with additional information as of 18-may-2020: 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 and passed.

• 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: 9595973
• MDR Text Key: 196071893
• Report Number: 1000113657-2020-00033
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292008888
• UDI-Public: (01)00021292008888
• 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,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/21/2020
• Device Model Number: STRIP, CVS 25CT TT
• Device Catalogue Number: A4H01-81
• Device Lot Number: RV5276
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/23/2019
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1