inforMED
OtherKSS

CAPTURE-R READY SCREEN I AND II TEST WELLS

Received Aug 22, 2002 · Event occurred Jun 22, 2002

Report 1034569-2002-00001 · MDR key 413268

Device

Generic name

Solid Phase Assay

Manufacturer

Immucor, Inc.

Model number

NA

Catalog number

0005042 AND 0005047

Lot number

X70

Product problems

  • Other (for use when an appropriate device code cannot be identified)

Patient

63 YR

  • Transfusion with incompatible blood
  • Fever
  • Reaction

Narrative

Description of Event or Problem

AFTER RECEIVING TWO UNITS OF PACKED RED BLOOD CELLS, A PATIENT DEVELOPED A FEVER AND EXPERIENCED A TRANSFUSION REACTION. THE USER FACILITY RETESTED THE TRANSFUSED RED CELL UNITS. ONE UNIT WAS FOUND TO BE JKA+. THE AHG CROSSMATCH REPEATED DURING THE INVESTIGATION WAS IMCOMPATIBLE WITH THIS UNIT.