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

Model Number STRIP, WALGREENS 100CTKETONE #383239

Device Problem Material Discolored (1170)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Note: manufacturer contacted customer in follow-up e-mail to ensure the initial concern is resolved - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint via e-mail for the ketone test strips.Customer stated in the e-mail that he had just opened a 50 count vial and that the ketone test strips were dark grey in color.The test strip lot manufacturer¿s expiration date is 09/30/2021 and product storage was not disclosed.No symptoms or medical attention associated with the use of the product was reported.No further information was provided.

Manufacturer Narrative

Sections with additional information as of 24-may-2021: h6: updated fda's type of investigation, investigation findings, and investigation conclusions h10: ketone strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested and passed within specifications added 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
• MDR Report Key: 11718432
• MDR Text Key: 249453814
• Report Number: 1000113657-2021-00276
• Device Sequence Number: 1
• Product Code: JIN
• UDI-Device Identifier: 00021292008178
• UDI-Public: 021292008178
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2021

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: 09/30/2021
• Device Model Number: STRIP, WALGREENS 100CTKETONE #383239
• Device Lot Number: AX577
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/24/2021
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1