MalfunctionJZS
BECKMAN COULTER CZE 2000 SYSTEM
Received Nov 23, 1999 · Event occurred Oct 11, 1999
Report 2050012-1999-00005 · MDR key 252143
Device
Generic name
Column Electrophoresis System
Manufacturer
Beckman Coulter, Inc.Model number
CZE 2000Catalog number
465500
Lot number
*
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
CUSTOMER STATES THAT A SIGNIFICANT IGG KAPPA MONOCLONAL PROTEIN WAS NOT IDENTIFIED ON APT WHEN USING THE CZE ELECTROPHORESIS SYSTEM. WHEN RERUN USING THE PARAGON GEL ELECTROPHORESIS SYSTEM, THE MONOCLONAL FRACTION WAS IDENTIFIED. THE CZE SYSTEM LABELING DESCRIBES THE POTENTIAL FOR THE SYSTEM TO MISS A SMALL MONOCLONAL FRACTIONS. MONOCLONAL PROTEINS MAY BE INDICATIVE OF SERIOUS ILLNESS AND DISEASE STATES AND A SIGNIFICANT MONOCLONAL THAT IS NOT IDENTIFIED COULD LEAD TO INCORRECT DIAGNOSIS OR INAPPROPRIATE TREATMENT.