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

Model Number	STRIP, WALGREENSKETONE 50CT #496636
Medical Device Problem Code	Unexpected Color (4055)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Note 1: manufacturer contacted customer in follow-up calls on 28-sep-2021 and 04-oct-2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated she had received the replacement product but had not yet used it.Note 2: 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.
Event or Problem Description
Consumer reported complaint for the ketone test strips (physical defect/color does not match chart on vial).Complaint was initially reported via e-mail and customer was contacted via telephone.Customer stated she had purchased a 50 count vial of test strips and that they turned brown when she performed a test.Customer stated the brown color is very different than the color she expected and is used to.The package had not been open or damaged when received by the customer.The test strip lot manufacturer¿s expiration date is 09/27/2022 and the test strips were opened one week prior to call.The product is not stored according to specification (bathroom).The customer did not have another vial of test strips that had been stored and handled correctly.The customer is using the ketone test strips for a keto diet.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.
Additional Manufacturer Narrative
Sections with additional information as of 01-dec-2021: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: ketone test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strips tested within specifications most likely underlying root cause: mlc-020: user's test strip had poor storage.

• 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: 12638300
• Report Number: 1000113657-2021-00652
• Device Sequence Number: 3984075
• 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): 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: 09/27/2022
• Device Model Number: STRIP, WALGREENSKETONE 50CT #496636
• Device Lot Number: AY607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/20/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 10/15/2021
• 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