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

Model Number STRIP, CVS 100CT KETONE

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Test strips vial was 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 - able to establish contact with customer and stated replacement product resolved initial concern.

Event Description

Consumer reported complaint for open vial, stating that one of the ketone test strip vials she had purchased had been opened.Customer stated that the box had been sealed.Customer stated that she did not use the ketone test strips.The customer feels well and did not report any symptoms.Medical attention was not required at an earlier time.

Manufacturer Narrative

Sections with additional information as of 27-mar-2020: h6: updated fda's method, result, and conclusion codes.H10: ketone test strips were returned for evaluation.Defect was detected; discolored grey color does not match chart on vial.H10: returned product was forwarded to packaging based on complaint's description.Internal evaluation has been completed and no abnormalities observed during packaging evaluation.Corrected sections as of 27-mar-2020: h10: most likely underlying root cause corrected from "mlc-9: user error caused or contributed to event" to "rc-61: storage outside specification".

• Brand Name: KETONE TEST STRIP
• 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: 9732922
• MDR Text Key: 221569256
• Report Number: 1000113657-2020-00092
• Device Sequence Number: 1
• Product Code: JIN
• UDI-Device Identifier: 021292008178
• UDI-Public: (01)021292008178
• Combination Product (y/n): N
• PMA/PMN Number: K000000
• 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: 03/27/2020

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: 11/22/2020
• Device Model Number: STRIP, CVS 100CT KETONE
• Device Lot Number: AW483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Distributor Facility Aware Date: 01/23/2020
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 03/26/2020
• Supplement Dates FDA Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1