MAUDE Adverse Event Report: TRIVIDIA HEALTH INC KETONE; NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)

Model Number	STRIP, KETONE 50CT
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Ketone test strips were returned for evaluation.Evaluation in process.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2021 to ensure the replacement products resolved the initial concern-able to establish contact with customer.Customer stated initial concern has been resolved and they are satisfied with the replacement.
Event or Problem Description
Consumer reported complaint for the ketone test strips.Customer stated she had purchased 100 count (two vials of 50) of the ketone test strips and one of the test strip vials had been partially open when received.Customer stated that the box/seal did not appear to be tampered with.The customer is using the product for the first time out of this package.Customer had tested using test strips from the vial (negative).The customer feels well and did not report any symptoms.No medical attention related to the use of the product was reported.
Additional Manufacturer Narrative
Sections with additional information as of 07-jan-2022: h3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: returned product was forwarded for internal evaluation.The packaging records were reviewed.The review of the work order showed no abnormalities.All the required sign offs for quality checks were completed by packaging and quality control.Due to the fact that ketone vials are manually packed it is believed that the vial became open after leaving trividia health facility.Ketone strips were returned for evaluation.Defect found on returned strips: physical defect of strips; discolored grey pads.Retention testing was performed using test strips from the same lot.Retention strips tested within 6 months passed within specifications.Root cause: rc-078: improperly shipped.

• Brand Name: KETONE
• Common Device Name: NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
• 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: 13014085
• Report Number: 1000113657-2021-00779
• Device Sequence Number: 11961185
• Product Code: JIN
• UDI-Device Identifier: 00021292008178
• UDI-Public: 021292008178
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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): 01/07/2022

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: 12/22/2022
• Device Model Number: STRIP, KETONE 50CT
• Device Lot Number: AY615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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