inforMED
MalfunctionJGY

CHOLESTECH LDX

Received Apr 11, 2001 · Event occurred Nov 1, 2000

Report MW1021594 · MDR key 326760

Device

Generic name

Analyzer-cholesterol And Glucose

Manufacturer

Cholestech Corp.

Model number

05625

Catalog number

10-004

Lot number

C08 3108 - 7 BOXES

Product problems

  • Use of Incorrect Control/Treatment Settings
  • Device Issue

Patient

*

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

CHOLESTEROL CASSETTE - NO REACTION WOULD OCCUR. CHOLESTEROL HIGH AND LOW CONTROLS WERE OUT OF RANGE.