MAUDE Adverse Event Report: TRIVIDIA HEALTH INC KETONE TEST STRIPS; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number STRIP, WALGREENS 100CTKETONE #383239

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2020

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-9: user error caused or contributed to event.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for open vial of ketone strips.The customer did not report symptoms.Medical attention is not reported as a result.The product storage location is undisclosed.The ketone test strip lot manufacturer¿s expiration date is 08/31/2021 and open vial date is undisclosed.

Manufacturer Narrative

Sections with additional information as of 03-sep-2020: h6: updated fda's method, result, and conclusion codes.H10: ketone test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested and passed.

Manufacturer Narrative

Sections with additional information as of 02-oct-2020: complaint was forwarded to packaging based on complaint's description for investigations.No product was returned to thi.Internal evaluation has been completed by packaging and no abnormalities observed.

• Brand Name: KETONE TEST STRIPS
• Type of Device: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 10167265
• MDR Text Key: 205540325
• Report Number: 1000113657-2020-00412
• 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: 10/02/2020

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?: No
• Distributor Facility Aware Date: 05/20/2020
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 08/06/2020; 09/21/2020
• Supplement Dates FDA Received: 09/03/2020; 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1