AXSYM RUBELLA LGG ANTIBODY
Received Mar 12, 2009 · Event occurred Feb 7, 2008
Report 1415939-2008-00294 · MDR key 1341440
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
Additional Manufacturer Narrative
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER CONTACTED ABBOTT REPORTING CALIBRATION FAILURE FOR THE AXSYM RUBELLA LGG ASSAY, WHERE ERROR CODE 1111 (CALIBRATION CHECK FAILURE, M-CAL 1, RESPONSE TOO LARGE) WAS GENERATED. THE CUSTOMER STATED THE RUBELLA REAGENT AND CALIBRATORS WERE NEW. THE CUSTOMER REVIEWED TROUBLESHOOTING PROCEDURES WITH ABBOT REPRESENTATIVE AND WAS ADVISED TO CENTRIFUGE THE CALIBRATORS. THE CUSTOMER REPORTED RECALIBRATION WAS SUCCESSFUL AND QUALITY CONTROLS WERE WITHIN RANGE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED BY THE CUSTOMER.
Remedial action
- Other