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

Model Number STRIP, WALGREENSKETONE 50CT #496636

Device Problem Material Discolored (1170)

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

Event Date 03/03/2023

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Most likely underlying root cause: mlc-028: there was not enough information to determine the mlurc.Note: manufacturer contacted customer in a follow-up call on 21-mar-2023 to ensure the replacement products resolved the initial concern: able to establish contact with customer who stated replacement products resolved initial concern.

Event Description

Consumer reported complaint for the ketone test strips.Customer stated that some of the ketone test strips are grey in color.The package had not been open or damaged when received by the customer.Customer has been using the product out of this package since (b)(6) 2023.The product is stored according to specification and is being properly handled.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.Customer declined to perform a test during the call.

Manufacturer Narrative

Sections with additional information as of 19-apr-2023: h6: updated fda¿s type, findings and conclusions codes.H10: ketone test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.

• 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: 16628575
• MDR Text Key: 312422206
• Report Number: 1000113657-2023-00167
• 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
• Report Date: 04/19/2023

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: 12/31/2023
• Device Model Number: STRIP, WALGREENSKETONE 50CT #496636
• Device Lot Number: AA660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/03/2023
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 04/19/2023
• 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