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

Model Number STRIP, WALGREENS 100CTKETONE #383239

Device Problem Material Discolored (1170)

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

Event Date 06/28/2022

Event Type  malfunction  

Event Description

Consumer reported complaint for the ketone test strips.Customer stated that when he opened the vial the ketone test strips had been grey in color.Customer also stated that the test strips did not change color when he tested.The package had not been open or damaged when received by the customer.This is the first time the customer is using the product out of the package.The product is stored according to specification in the living area.The test strip lot manufacturer¿s expiration date is 03/13/2023 and open vial date was not disclosed.The customer feels well and did not report any symptoms and no 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 - product evaluation in-process.Note: manufacturer contacted customer in a follow-up call on 07-jul-2022 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

Manufacturer Narrative

Sections with additional information as of 19-aug-2022: h3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: ketone strips were returned for evaluation.Defect found on returned strips: physical defect of strips; discolored grey pads.No further investigation required.Product evaluation has been completed.Added root cause : rc-061: storage outside 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: 15084571
• MDR Text Key: 304549131
• Report Number: 1000113657-2022-00413
• 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: 08/19/2022

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: 03/13/2023
• Device Model Number: STRIP, WALGREENS 100CTKETONE #383239
• Device Lot Number: AY628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/28/2022
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 08/19/2022
• 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