AXSYM RUBELLA LGG ANTIBODY

Description of Event or Problem

THE CUSTOMER REPORTED CALIBRATION FAILURE FOR THE ABBOTT AXSYM RUBELLA LGG ASSAY, WHERE ERROR CODE 1048 (CALIBRATION CHECK FAILURE, CAL A/B, RATIO TOO LARGE) WAS GENERATED. ABBOTT REQUESTED THE CUSTOMER FAX THE FAILED CALIBRATION DATA FOR EVALUATION AND REVIEWED TROUBLESHOOTING PROCEDURES, WHICH INCLUDED USING WATER INSTEAD OF CALIBRATOR IN POSITION 1. THE CUSTOMER REQUESTED A NEW LOT OF RUBELLA MASTER CALIBRATORS AND DIDN'T WANT TO CENTRIFUGE THE CALIBRATORS UNTIL NEW CALIBRATORS WERE RECEIVED. THE CUSTOMER REPORTED UPON RECEIPT OF THE NEW CALIBRATORS, THE CALIBRATION STILL FAILED WITH CALIBRATOR A TOO HIGH. THE CUSTOMER WAS ADVISED TO CENTRIFUGE THE CALIBRATORS AND RECALIBRATE. THE CUSTOMER REPORTED RECALIBRATION OF CENTRIFUGATION OF CALIBRATORS PRODUCED THE SAME ERROR CODE 1048 AND WAS SENT A NEW LOT REAGENT. A SUCCESSFUL CALIBRATION WAS ACHIEVED WITH THE NEW REAGENT AND CENTRIFUGED CALIBRATORS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED BY THE CUSTOMER.

Additional Manufacturer Narrative

(NO CONSEQUENCE OR IMPACT TO PATIENT). (CALIBRATION ERROR). (ERROR MESSAGE GIVEN). THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.