inforMED
MalfunctionCDM

DIASCREEN 10 REAGENT STRIPS

Received Jul 25, 2012 · Event occurred Jul 18, 2012

Report MW5026293 · MDR key 2675742

Device

Generic name

Reagent Strips

Manufacturer

Ark Ray Usa Inc.

Lot number

01042A

Product problems

  • Device Operates Differently Than Expected

Patient

Not reported

  • No Information

Narrative

Description of Event or Problem

DIASCREEN 10 REAGENT STRIPS, LOT 01042A, EXP 05/2013 APPEARED TO GIVE FALSE RESULT.