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

Model Number STRIP, WALGREENSKETONE 50CT #496636

Device Problems Material Discolored (1170); No Device Output (1435); Unsealed Device Packaging (1444)

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

Event Date 11/02/2023

Event Type  malfunction  

Event Description

Consumer reported complaint for the trueplus ketone test strips.Mother is calling on behalf of the customer.Caller stated that when she opened the box of ketone test strips, the vial had been opened.Caller advised that the box was a little crushed as if it was stepped on, but it was sealed.Caller advised that the ketone test strip padding was grey in color, and that she did have customer try to use the strips but there was no change in color.The customer feels well and did not report any symptoms, no medical attention related to the use of the product was reported.

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were returned for evaluation.Defect found on returned strips: physical defect of strips; discolored grey pads.Complaint was forwarded to packaging and internal evaluation completed.Packaging records were reviewed, no abnormalities observed.Retention testing was performed using test strips from the same lot.Retention strips tested within specifications.Most likely underlying root cause: mlc-063: damaged during transit.Note: manufacturer contacted customer in a follow-up call (b)(6) 2023 to ensure the customer¿s replacement products resolved the initial concern, able to contact customer who stated they are comfortable with the readings from the replacement products.

• 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: 18230184
• MDR Text Key: 329273260
• Report Number: 1000113657-2023-00571
• Device Sequence Number: 1
• Product Code: JIN
• UDI-Device Identifier: 021292008178
• UDI-Public: (01)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: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/29/2023

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: 04/15/2024
• Device Model Number: STRIP, WALGREENSKETONE 50CT #496636
• Device Lot Number: AA667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Distributor Facility Aware Date: 11/02/2023
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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