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

Model Number STRIP, CVS KETONE 50CTDIET

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were returned and pending qc evaluation.Note: manufacturer contacted customer in a follow-up call on 16-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 ketone strips sticking together.The customer did not report symptoms and no medical attention was reported as a result.The product is not stored according to specification in the bathroom.The test strip lot manufacturer¿s expiration date is 09/30/2021 and open vial date is one week and a half ago.

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.).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 and defect was detected.Ketone test strips were observed partly stuck together, however test results were within range.Internal evaluation has been completed by packaging and no abnormalities observed.Most likely underlying root cause: rc-077 user error caused or contributed to event.Note: manufacturer contacted customer in a follow up 11-nov-2020 to advise and educate customer on related issues found during product evaluation.

Manufacturer Narrative

Corrected sections as of 05-oct-2020: d2: product code corrected from nbw to jin.

• 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: 10627144
• MDR Text Key: 234883212
• Report Number: 1000113657-2020-00726
• 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,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: 09/30/2021
• Device Model Number: STRIP, CVS KETONE 50CTDIET
• Device Lot Number: AX574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Distributor Facility Aware Date: 09/09/2020
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 09/09/2020; 10/27/2020
• Supplement Dates FDA Received: 10/05/2020; 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1