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

Model Number	STRIP, WALGREENSKETONE 50CT #496636
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
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.Manufacturer contacted customer in several follow-up calls to ensure the replacement product 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.Customer stated that when he opened the vial, the padding on the ketone test strips were all grey in color.Customer stated that the product had been sealed and intact when purchased.The ketone test strip lot manufacturer¿s expiration date is 10/23/2022 and open vial date is 01/23/2022.The customer feels well and did not report any symptoms and medical attention related to the use of the product was not reported.

• 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: 13559860
• Report Number: 1000113657-2022-00090
• Device Sequence Number: 5104397
• 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): 02/18/2022

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: 10/23/2022
• Device Model Number: STRIP, WALGREENSKETONE 50CT #496636
• Device Lot Number: AY611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Distributor Facility Aware Date: 01/24/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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