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

Model Number	STRIP, WALGREENS 100CTKETONE #383239
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Ketone test strips were returned for evaluation.Product testing was performed and defect found: physical defect of strips; discolored grey pads.Root cause: rc-061: storage outside specifications.Note: manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for physical defect of the ketone test strips.Customer stated she had just purchased 100 count (two vials) of the ketone test strips.Customer stated the test strips in one vial were grey in color and the test strips in the other vial were pink/flesh tone in color.Customer stated she had not used any of the test strips from the vial where the test strips had been grey in color.The package had not been open or damaged when received by the customer and there was no evidence of the product being used previously.The test strip manufacturer¿s expiration date is 08/16/2022 and customer stated she is storing and handling the test strips correctly (location undisclosed).The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.Customer declined to perform a 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: 12598119
• Report Number: 1000113657-2021-00636
• Device Sequence Number: 1494933
• Product Code: JIN
• UDI-Device Identifier: 00021292008178
• UDI-Public: 021292008178
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/08/2021

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: 08/16/2022
• Device Model Number: STRIP, WALGREENS 100CTKETONE #383239
• Device Lot Number: AX604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Distributor Facility Aware Date: 09/14/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1