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

Model Number	STRIP, CVS 100CT KETONE
Medical Device Problem Codes	Material Discolored (1170); No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Ketone test strips were returned for evaluation.Defect found on returned strips: physical defect of strips; discolored grey pads root cause: rc-061: storage outside specifications note: manufacturer contacted customer in a follow-up call on 18-aug-2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer.Customer states replacement products resolved customer¿s initial issue.
Event or Problem Description
Consumer reported complaint for the ketone test strips.Complaint was initially reported via e-mail and then by telephone.Customer stated she had purchased 2 vials of 50 test strips.The package had not been open or damaged when received by the customer.Customer stated the tips of the test strips from the first vial were grey in color and those from the second vial were beige.Customer tested using both vials and stated the first vial provided a negative trace and the second vial showed moderate.The test strip lot manufacturer¿s expiration date is 07/16/2022.The product storage and open vial date were not disclosed.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.The customer declined to perform a urine test during the call.

• 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
• MDR Report Key: 12380525
• Report Number: 1000113657-2021-00513
• Device Sequence Number: 4104923
• Product Code: JIN
• UDI-Device Identifier: 00021292008178
• UDI-Public: 021292008178
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 08/27/2021

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: 07/16/2022
• Device Model Number: STRIP, CVS 100CT KETONE
• Device Lot Number: AX599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Distributor Facility Aware Date: 08/01/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2021
• Initial Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1