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

Model Number STRIP, CVS 100CT KETONE

Device Problem Material Discolored (1170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

Sections with additional information as of 01-dec-2021: device evaluated by manufacturer.Updated fda¿s type, findings and conclusions codes.Ketone strips were returned for evaluation.Defect found on returned strips: physical defect (discolored grey pads).Root cause: rc-061: storage outside specifications.

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were returned for evaluation.Investigation in process note: manufacturer made several attempts to contact customer to ensure the replacement products resolved the initial concern - unable to establish contact with customer.

Event Description

Consumer reported complaint for physical defect of the ketone test strips.Customer stated the ketone test strip pads are grey/brown in color.The package had not been open or damaged when received by the customer.The product is not stored according to specification (bathroom).The test strip lot manufacturer¿s expiration date is 06/30/2022 and test strips were opened one month ago.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.

• 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: 12738523
• MDR Text Key: 281963812
• Report Number: 1000113657-2021-00693
• 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: 06/30/2022
• Device Model Number: STRIP, CVS 100CT KETONE
• Device Lot Number: AX601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/07/2021
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 11/02/2021
• 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