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 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were returned for evaluation, defect was detected.Root cause: rc-061: storage outside specifications.Manufacturer contacted customer in a follow-up call on 26-jan-2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.

Event Description

Complaint received via email.Consumer reported complaint for physical defects/discolored grey of ketone strips.Customer stated that purchased a box of ketone test strips and found that the lot # may be bad.The customer stated that the strips are all grey in color and they do not turn purple color when used.The customer did not report symptoms.Medical attention is not reported as a result.The product storage location is undisclosed.The ketone test strip open vial date is (b)(6) 2021.

• 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
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 11314400
• MDR Text Key: 231743299
• Report Number: 1000113657-2021-00099
• 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
• Report Date: 02/11/2021

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: 07/31/2021
• Device Model Number: STRIP, CVS 100CT KETONE
• Device Lot Number: AW560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Distributor Facility Aware Date: 01/14/2021
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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