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

Model Number STRIP, WALGREENS 100CTKETONE #383239

Device Problem Labelling, Instructions for Use or Training Problem (1318)

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

Event Date 11/16/2023

Event Type  malfunction  

Event Description

Consumer reported complaint for the trueplus ketone test strips.Customer stated that the color guide on the ketone test strips that lets you know how far in ketosis you are is not correct.Customer stated that the "trace" color on the bottle is too dark and should be lighter, as she has bought our ketone test strips before and the color on the label was lighter for the "trace." customer has no complaint that the product is not working, just that she feels that the labeling is off.The customer feels well and did not report any symptoms and medical attention related to the use of the product was not reported.

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were returned for evaluation.Evaluation in process.Note: manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.

Manufacturer Narrative

Corrected sections as of 08-jan-2024: h2: if follow up what type: additional information corrected from no to yes.Device evaluation corrected from no to yes.

Manufacturer Narrative

Sections with additional information as of 08-jan-2024: h3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: ketone test strips were returned for evaluation.Product testing was performed and no defect found on returned test strips.Returned product was forwarded to production operations.Internal evaluation was completed and no abnormalities observed on returned product.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: mlc-001: user had an inaccurate reference.

• 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: 18320957
• MDR Text Key: 330963799
• Report Number: 1000113657-2023-00609
• 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: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2024

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 Model Number: STRIP, WALGREENS 100CTKETONE #383239
• Device Lot Number: AB697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/16/2023
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 12/14/2023; 12/14/2023
• Supplement Dates FDA Received: 01/08/2024; 01/08/2024
• 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