inforMED
MalfunctionJIL

CLINITEK STATUS+

Received Apr 13, 2023 · Event occurred Mar 16, 2023

Report 3002637618-2023-00020 · MDR key 16736532

Device

Generic name

Method, Enzymatic, Glucose (urinary, Non-quantitative)

Catalog number

10379675

Lot number

207024

Product problems

  • Low Test Results
  • Low Test Results

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

CUSTOMER STATES THAT THEY RECEIVED A DISCREPANT PROTEIN RESULT COMPARED TO RETESTING ON A LAB INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

Additional Manufacturer Narrative

PROPER MAINTENANCE AND TECHNIQUE WERE REVIEWED WITH THE CUSTOMER. THE CUSTOMER WAS NOT FOLLOWING THE INSTRUMENT MANUAL INSTRUCTIONS. THE CAUSE OF THIS EVENT IS USER ERROR.