CAPTURE-R READY-SCREEN TEST WELLS
Received May 9, 2007 · Event occurred Apr 11, 2007
Report 1034569-2007-00103 · MDR key 970149
Device
Product problems
- False Negative Result
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WITH A PT SAMPLE WITH A HISTORY OF ANTI-E DETECTED, USING CAPTURE-R READY-SCREEN, LOT X185 ON THE GALILEO. THE SAMPLE WAS REPEATED ON THE GALILEO; THE REPEAT SCREEN WAS NEGATIVE. THE CUSTOMER TESTED THE SAMPLE USING AN ALTERNATE METHOD AND ANTI-E WAS DETECTED.
Additional Manufacturer Narrative
THE PRESENCE OF E ANTIGEN WAS CONFIRMED ON RETENTION CAPTURE-R READY-SCREEN (CRRS), LOT X185. THE CUSTOMER RETURNED TWO SAMPLES FOR INVESTIGATION TESTING. TESTING ON AN IN-HOUSE GALILEO USING RETENTION CRRS, X185 WAS NEGATIVE. THE SAMPLES WERE TESTED BY MANUAL TUBE METHOD WITH PANOSCREEN REAGENT RED BLOOD CELLS, LOT 11845 USING IMMUADD AS THE POTENTIATOR. ONE SAMPLE DEMONSTRATED VERY WEAK REACTIVITY WITH CELL II (R2R2) AT THE 37 C AND ANTIGLOBULIN PHASES OF TESTING. THE OTHER SAMPLE WAS NONREACTIVE AT ALL PHASES OF TESTING. THE LIMITATIONS SECTION OF THE PACKAGE INSERT FOR CAPTURE-R READY-SCREEN STATES: "NEGATIVE REACTIONS WILL BE OBTAINED OF THE TEST SERUM CONTAINS ANTIBODIES PRESENT IN CONCENTRATIONS TOO LOW TO BE DETECTED BY THE TEST METHODS EMPLOYED." THE EVENT APPEARS TO BE RELATED TO THE NATURE OF THE SPECIMEN.