ARCHITECT LH
Received Dec 28, 2006 · Event occurred Dec 1, 2006
Report 1415939-2006-00081 · MDR key 809064
Device
Generic name
Cmia For The Quantitative Determination Of Human Luteinizing
Manufacturer
Abbott LaboratoriesModel number
NACatalog number
6C25-22
Lot number
33198M200
Product problems
- Other (for use when an appropriate device code cannot be identified)
- Device Displays Incorrect Message
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE ACCOUNT GENERATED ERROR 1227 ASSAY (LH) NUMBER (461) CALIBRATION FAILURE, RATIO TOO LARGE FOR CALIBRATOR F, WHEN PROCESSING THE ARCHITECT LH ASSAY. THE ACCOUNT ALSO STATED THE CONTROLS ARE TRENDING DOWNWARD AND ARE LOW. NO RESULTS WERE REPORTED OUTSIDE OF THE LAB. NO IMPACT TO PT MGMT WAS REPORTED.
Additional Manufacturer Narrative
THIS ISSUE WAS IDENTIFIED WHILE INVESTIGATING AN INCREASE IN CUSTOMER COMPLAINTS FOR UPWARD SHIFTS IN NON-ABBOTT CONTROL AND PT SAMPLE RESULTS, AS WELL AS CALIBRATION ERRORS. SPECIFICALLY, ERROR CODES 1227 "ASSAY (LH) NUMBER (641) CALIBRATION FAILURE, FIT CONCENTRATION TOO HIGH FOR CAL F" MAY BE GENERATED, WHICH COULD RESULT IN FAILURE TO OBTAIN A VALID CALIBRATION CURVE. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Remedial action
- Recall