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 Consequences Or Impact To Patient (2199)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

Internal reference number: (b)(4).Ketone test strips were not returned for evaluation.Most likely underlying root cause: mlc-061 improper use / mishandled by end user.Note: manufacturer contacted customer in a follow-up call 24-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 discoloration of strips.The customer did not report symptoms.Medical attention is not reported as a result.The product storage location is undisclosed.The test strip lot manufacturer¿s expiration date is 09/23/2021 and open vial date is undisclosed.Complaint summary: customer when open you that ketone test strips are grey in color.Customer is feeling well at this time and is not having any diabetic symptoms.

Manufacturer Narrative

Sections with additional information as of 7-jan-2020: d10 - h3: product available for evaluation.H6: updated fda's method, result, and conclusion codes.H10: ketone test strips were returned for evaluation.Defect found on returned strips: physical defect of strips and discolored grey pads.Update most likely underlying root cause from mlc-061: improper use / mishandled by end user to 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
• MDR Report Key: 10900255
• MDR Text Key: 228921149
• Report Number: 1000113657-2020-00848
• Device Sequence Number: 1
• Product Code: JIN
• UDI-Device Identifier: 021292008178
• UDI-Public: (01)021292008178
• 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: 01/07/2021

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: 09/23/2021
• Device Model Number: STRIP, WALGREENSKETONE 50CT #496636
• Device Lot Number: AX570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Distributor Facility Aware Date: 10/28/2020
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1