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

Model Number STRIP, CVS 100CT KETONE

Device Problems Material Discolored (1170); Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were returned - product evaluation in-process.Most likely underlying root cause still pending of investigation completion manufacturer contacted customer in a follow-up call on 2-dec-2020 to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated replacement products are working as intended.

Event Description

Consumer reported complaint for physical defect and open vial of ketone test strips.The customer feels well and did not reported any symptoms and no medical intervention was reported.Customer stated she had purchased 100 count box of ketone test strips and one vial had been closed, the tips of the strips were nude color and the other vial had been opened the tips of the strips were grey color.Customer did not perform any tests using strips from the vial that had been open.The product storage location and open vial date was undisclosed.

Manufacturer Narrative

Sections with additional information as of 30-dec-2020: h3: device evaluated by manufacturer: yes h6: updated fda's method, result, and conclusion codes h10: ketone test strips were returned for evaluation and physical defect found.Rc-078: improperly shipped.

• Brand Name: KETONE TEST STRIPS
• Type of Device: NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 10939053
• MDR Text Key: 219546652
• Report Number: 1000113657-2020-00867
• Device Sequence Number: 1
• Product Code: JIN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

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: 09/20/2021
• Device Model Number: STRIP, CVS 100CT KETONE
• Device Lot Number: AX568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Distributor Facility Aware Date: 11/05/2020
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 12/03/2020
• Supplement Dates Manufacturer Received: 12/03/2020
• Supplement Dates FDA Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1