AXSYM RUBELLA LGG ANTIBODY
Received Mar 12, 2009 · Event occurred Feb 1, 2008
Report 1415939-2008-00292 · MDR key 1341438
Device
Generic name
Meia For The Measurement Of Lgg Antibody To The Rubella Virus
Manufacturer
Abbott LaboratoriesModel number
NACatalog number
3B23-20
Lot number
56323M101
Product problems
- Calibration Error
- Device Displays Incorrect Message
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER CONTACTED ABBOTT REGARDING MASTER CALIBRATION ERROR CODE 1061 (MASTER CALIBRATION FAILURE, INCOMPLETE CALIBRATOR RESULTS) FOR THE AXSYM RUBELLA LGG ASSAY. THE CUSTOMER REPORTED THAT ANOTHER FAILED CALIBRATION OCCURRED IN 2008 WITH CALIBRATION DEVIATION TOO LARGE BETWEEN TWO POINTS. THE CUSTOMER WAS ADVISED TO REPLACE AND CALIBRATE THE SAMPLE PROBE AND ATTEMPT RECALIBRATION. THE CUSTOMER REPORTED RECALIBRATION FAILED AND ERROR CODE 1048 (CALIBRATION CHECK FAILURE, CAL A/B, RATIO TOO LARGE) WAS GENERATED. THE CUSTOMER WAS ADVISED TO CENTRIFUGE THE CALIBRATORS AND RECALIBRATE. RECALLIBRATION OF THE RUBELLA LGG ASSAY WAS SUCCESSFUL AFTER CALIBRATOR CENTRIFUGATION AND QUALITY CONTROLS WERE IN RANGE. 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.
Remedial action
- Other