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

Model Number STRIP, CVS 100CT KETONE

Device Problem Material Discolored (1170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2020

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.Note: manufacturer contacted customer in a follow-up call on 16-nov-2020 to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.

Event Description

Consumer reported complaint for physical defects on the ketone strips.Customer bought 2 vials of 50 count ketone strips and some of the pads at end of the strips were missing and stuck together, when customer pulled some of the strips apart the pads also came off of the some of the ketone strips.The customer did not reported symptoms or any medical attention.The product storage location was undisclosed.The test strip lot manufacturer¿s expiration date is 09/30/2021 and open vial date was couple of weeks ago.

Manufacturer Narrative

Sections with additional information as of 13-jan-2021: d10 - h3: product available for evaluation.H6: updated fda's method, result, and conclusion codes.H10: ketone test strips were returned - defect was detected.Root cause: rc-074: manufacturing processing error.

• 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: 10865318
• MDR Text Key: 222019287
• Report Number: 1000113657-2020-00839
• Device Sequence Number: 1
• Product Code: JIN
• UDI-Device Identifier: 021292008178
• UDI-Public: (01)021292008178(17)2
• 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: 01/13/2021

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: 09/30/2021
• Device Model Number: STRIP, CVS 100CT KETONE
• Device Lot Number: AX574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Distributor Facility Aware Date: 10/21/2020
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1