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

Model Number	STRIP, CVS 25CT TT
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter was returned for evaluation.Pending investigation.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 or Problem Description
Consumer reported complaint for missing package item, stating that the vial of test strips she had purchased was missing the code chip.Customer stated that the seal was on the test strip vial.The customer feels well and did not report any symptoms.No past medical attention was reported.
Additional Manufacturer Narrative
Sections with additional information as of 07-jul-2020: h6: updated fda's method, result, and conclusion codes.H10: returned product was forwarded to packaging based on complaint's description.Internal evaluation has been completed and no abnormalities observed.H10: most likely underlying root cause: mlc-9: user error caused or contributed to event.

• Brand Name: TRUETRACK
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 9938338
• Report Number: 1000113657-2020-00212
• Device Sequence Number: 13642003
• Product Code: NBW
• UDI-Device Identifier: 00021292008888
• UDI-Public: (01)00021292008888
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K032657
• 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): 07/07/2020

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: 11/16/2020
• Device Model Number: STRIP, CVS 25CT TT
• Device Catalogue Number: A4H01-81
• Device Lot Number: RW5263S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Distributor Facility Aware Date: 03/12/2020
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1