CAPTURE-R SELECT
Received Sep 24, 2008 · Event occurred Sep 1, 2008
Report 1034569-2008-00472 · MDR key 1171475
Device
Product problems
- False Negative Result
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
DURING GALILEO VALIDATION, UNEXPECTED NEGATIVE REACTIONS WERE OBSERVED USING CAPTURE-R SELECT. EIGHTY DONORS WERE TESTED AND HALF OF THEM DEMONSTRATED POSITIVE REACTIVITY WHEN TESTED WITH A SERUM KNOW TO CONTAIN ANTI-VEL.
Additional Manufacturer Narrative
THE CUSTOMER RETURNED A SAMPLE (REPORTED TO CONTAIN ANTI-VEL), IT WAS TESTED WITH PANOSCREEN, LOT 28317, USING IMMUADD AS THE POTENTIATOR. INCUBATIONS AT IS AND RT WERE INCLUDED. NO REACTIVITY WAS OBSERVED AT IS OR RT. VARIABLE REACTIVITY WAS OBSERVED AT IAT. THE CUSTOMER'S SAMPLE WAS ALSO TESTED WITH CAPTURE-R READY SCREEN (CRRS), LOT G140, AND CAPTURE-R SELECT, LOT SC050. THE SAMPLE WAS REACTIVE WITH CELL IV ON CRRS. THE SAMPLE WAS REACTIVE WITH ALL CELLS ON SELECT, LOT SC050. NO VEL-NEGATIVE DONOR CELLS WERE AVAILABLE FOR TESTING. THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION, THE RESULTS APPEAR TO BE DUE TO THE NATURE OF THE SAMPLE.