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

Model Number STRIP, WALGREENSKETONE 50CT #496636

Device Problem Unexpected Color (4055)

Patient Problem Insufficient Information (4580)

Event Date 09/20/2021

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 279377087
• Report Number: 1000113657-2021-00652
• Device Sequence Number: 1
• Product Code: JIN
• UDI-Device Identifier: 00021292008178
• UDI-Public: 021292008178
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 11/09/2021
• Supplement Dates FDA Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1