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

Model Number STRIP, CVS KETONE 50CT

Device Problem Material Discolored (1170)

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

Event Date 04/21/2022

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on 05-may-2022 to ensure the replacement product resolved the initial concern - able to establish contact with customer who stated replacement product resolved initial concern.

Event Description

Consumer reported complaint for the ketone test strips.Customer stated that the package was not opened or damaged when received.Customer stated the test strip vial was sealed and when she opened it, the color on the test strip pad was blue in color instead of beige.Customer did not perform any test using the test strips.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

Sections with additional information as of 26-july-2022: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: ketone test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strips tested within specifications.Most likely underlying root cause: mlc-050: manufacturing or packaging process caused malfunction of user's test strip.

• 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: 14454861
• MDR Text Key: 300355906
• Report Number: 1000113657-2022-00292
• 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: 07/26/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/23/2023
• Device Model Number: STRIP, CVS KETONE 50CT
• Device Lot Number: AY625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/21/2022
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 06/28/2022
• Supplement Dates FDA Received: 07/26/2022
• 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