MTS ANTI-IGG, -C3D CARD
Received May 8, 2009 · Event occurred Apr 14, 2009
Report 1056600-2009-00097 · MDR key 1458586
Device
Generic name
Anti-human Globulin Reagent
Manufacturer
Micro Typing Systems, Inc,Model number
NACatalog number
MTS4014
Lot number
071608005-04
Product problems
- False Negative Result
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT A DAT POSITIVE SAMPLE FAILED TO REACT IN THE MTS ANTI-IGG, -C3D CARD LOT# 071608005-04. THE SAMPLE REACTED POSITIVE (1+) USING THE MTS ANTI-IGG CARD. A FALSE NEGATIVE DAT MAY LEAD TO CONFUSION IN THE DIAGNOSIS OF ANEMIA OR MISDIAGNOSIS OF A HEMOLYTIC TRANSFUSION REACTION.
Additional Manufacturer Narrative
SATISFACTORY RESULTS WERE OBTAINED AT OCD USING RETAINED CARDS FROM MTS ANTI-IGG - C3D CARD LOT # 071608005-04 AND MTS ANTI-IGG CARD LOT # 112408001-30 USING KNOWN DAT POSITIVE AND NEGATIVE SAMPLES. THE GEL CARDS PERFORMED AS EXPECTED AT OCD. THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED. THE SAMPLE IN QUESTION WAS SUBMITTED TO OCD FOR ADD'L TESTING. A DEFINITE ROOT CAUSE WAS NOT DETERMINED REGARDING THE NEGATIVE RESULTS OBTAINED AT THE CUSTOMER SITE. A COMPLAINT REVIEW INDICATED NO OTHER COMPLAINTS HAVE BEEN LOGGED AGAINST LOT# 071608005-04. BATCH RECORD REVIEW WAS WITHIN RELEASE SPECIFICATIONS. INCIDENT IS ISOLATED. (B) (4).