AXSYM RUBELLA LGG ANTIBODY
Received Mar 12, 2009 · Event occurred Jan 31, 2008
Report 1415939-2008-00289 · MDR key 1341435
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 FAILED CALIBRATION OF THE AXSYM RUBELLA LGG ASSAY WHERE ERROR CODE 1048 (CALIBRATION CHECK FAILURE, CALA/B, RATIO TOO LARGE) WAS GENERATED. THE CUSTOMER DECONTAMINATED THE LINES, CLEANED AND CALIBRATED THE AXSYM OPTICS AND RECALIBRATED THE RUBELLA ASSAY, WHICH FAILED. THE CUSTOMER WAS ADVISED TO TROUBLESHOOT BY CENTRIFUGATION OF THE CALIBRATORS, AND WAS SENT A NEW LOT OF CALIBRATORS. UPON RECEIPT OF THE NEW CALIBRATORS, RECALIBRATION OF THE RUBELLA LGG ASSAY WAS ATTEMPTED AND FAILED. 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