AXSYM RUBELLA LGG ANTIBODY

Description of Event or Problem

THE CUSTOMER CONTACED ABBOTT REGARDING THREE ATTEMPTS TO CALIBRATE THE AXSYM RUBELLA LGG ASSAY WHICH FAILED, AND ERROR CODE 1111 (CALIBRATION CHECK FAILURE, M-CAL 1, RESPONSE TOO LARGE) WAS GENERATED. THE CUSTOMER REPORTED AXSYM MAINTENANCE WAS UP TO DATE. FOR TROUBESHOOTING, THE CUSTOMER ATTEMPTED CALIBRATION USING WATER INSTEAD OF MASTER CALIBRATOR 1, WHICH WAS SUCCESSFUL. THE CUSTOMER CLEANED THE INSTRUMENT OPTICS AND ATTEMPTED RECALIBRATION WHICH FAILED AGAIN WITH THE SAME ERROR MESSAGE. THE CUSTOMER WAS SENT NEW REAGENTS AND CALIBRATORS AND UPON RECALIBRATION WITH THE NEW MATERIAL, THE SAME CALLIBRATION FAILURE PERSISTED. THE CUSTOMER WAS ADVISED TO CENTRIFUGE CALIBRATOR A, THEN USE THE CENTRIFUGED CALIBRATOR IN THE RUBELLA RECALIBRATION WHICH WAS SUCCESSFUL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED BY THE CUSTOMER.

Additional Manufacturer Narrative

THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.