ANTI-HUMAN GLOBULIN ANTI-IGG
Received Aug 23, 2011 · Event occurred Jun 30, 2011
Report 9610824-2011-00107 · MDR key 2254835
Device
Generic name
Ahg Anti-igg
Manufacturer
Bio-rad Medical Diagnostics GmbhCatalog number
804175100
Lot number
7039091-04
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- Reaction
Narrative
Description of Event or Problem
THE CUSTOMER COMPLAINED THAT THEY MISSED AN INCOMPATIBLE CROSSMATCH CAUSED BY ANTI-IGG ART#: (B)(4), LOT 7039091-04. CUSTOMER REPORTED THEY DETECTED ANTI-JK(A) AND ANTI-FY(A) BUT MISSED AN ANTI-E AND GOT THEREFORE AN TRANSFUSION REACTION. CUSTOMER SENT US THE PT SAMPLE, THE COMPLAINT SAMPLE ANTI-IGG AND THE ANTI-IGG OF A COMPETITOR. THE PT SAMPLE WAS TESTED WITH THE ALLEGEDLY DEFECTIVE ANTI-IGG IN PARALLEL TO THE COMPETITOR'S ANTI-IGG. BOTH REAGENTS SHOWED COMPLETELY IDENTICAL REACTIONS. FURTHER TESTS SHOWED THAT THE ADD'L ANTIBODY WAS NOT AN ANTI-E BUT ANTI-K. THIS ANTIBODY COULD BE IDENTIFIED UNAMBIGUOUSLY WITH THE COMPLAINT SAMPLE ANTI-IGG, TESTING OF QUALITY CONTROL LAB CONFIRMED THE CORRECT FUNCTION OF THE COMPLAINED ANTI-IGG LOT. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE COMPLAINED LOT'S QUALITY.
Additional Manufacturer Narrative
(B)(4).