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

Model Number STRIP, WALGREENS 100CTKETONE #383239

Device Problem Material Discolored (1170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Most likely underlying root cause: mlc-61: improper use / mishandled by end user note: manufacturer contacted customer in a follow-up call on 28-sep-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 defect of ketone test strips, stating that half of the test strips were gray in color.Customer stated she had purchased the ketone test strips from (b)(6).Customer's information was provided to technician who was unable to contact the customer via telephone.No further information was able to be obtained.

Manufacturer Narrative

Corrected sections as of 18-nov-2020 d2: common device name corrected from system, test blood glucose, over the counter to nitroprusside, ketones (urinary, non-quant.).H7: remedial action selection corrected from other: unable to contact to replace.Sections with additional information as of 18-nov-2020 h6: updated fda's method, result, and conclusion codes.H10: ketone test strips were returned for evaluation, defect was detected: physical defect of strips; discolored grey pads.Retention results are acceptable.Most likely underlying root cause: rc-061 storage outside specifications.

• 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: 10631459
• MDR Text Key: 243535775
• Report Number: 1000113657-2020-00729
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

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: 08/31/2021
• Device Model Number: STRIP, WALGREENS 100CTKETONE #383239
• Device Lot Number: AX563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Distributor Facility Aware Date: 09/11/2020
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1