AXSYM RUBELLA LGG ANTIBODY
Received Mar 12, 2009 · Event occurred Feb 8, 2008
Report 1415939-2008-00299 · MDR key 1341441
Device
Generic name
Meia For The Measurement Of Lgg Antibody To The Rubella Virus
Manufacturer
Abbott LaboratoriesModel number
NACatalog number
3B23-20
Lot number
55922M101
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 TO REPORT FAILED AXSYM RUBELLA LGG CALIBRATIONS, WHERE ERROR CODE 1111 (CALIBRATION CHECK FAILURE, M-CAL 1, RESPONSE TOO LARGE) WERE GENERATED. THE CUSTOMER WAS ADVISED TO CENTRIFUGE THE MASTER CALIBRATORS AND RECALIBRATE. THE CUSTOMER CALLED BACK TO REPORT THE CALIBRATION WAS SUCCESSFUL AND THE ISSUE WAS RESOLVED. 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.
Remedial action
- Other