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

Model Number	STRIP, CVS 100CT KETONE
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sections with additional information as of 01-dec-2021: device evaluated by manufacturer.Updated fda¿s type, findings and conclusions codes.Ketone strips were returned for evaluation.Defect found on returned strips: physical defect (discolored grey pads).Root cause: rc-061: storage outside specifications.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Ketone test strips were returned for evaluation.Investigation in process note: manufacturer made several attempts to contact customer to ensure the replacement products resolved the initial concern - unable to establish contact with customer.
Event or Problem Description
Consumer reported complaint for physical defect of the ketone test strips.Customer stated the ketone test strip pads are grey/brown in color.The package had not been open or damaged when received by the customer.The product is not stored according to specification (bathroom).The test strip lot manufacturer¿s expiration date is 06/30/2022 and test strips were opened one month ago.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.

• 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: 12738523
• Report Number: 1000113657-2021-00693
• Device Sequence Number: 20037662
• Product Code: JIN
• UDI-Device Identifier: 00021292008178
• UDI-Public: 021292008178
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/01/2021

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: 06/30/2022
• Device Model Number: STRIP, CVS 100CT KETONE
• Device Lot Number: AX601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/07/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 12/01/2021
• 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