ARCHITECT LH
Received Dec 27, 2006 · Event occurred Aug 18, 2006
Report 1415939-2006-00078 · MDR key 820277
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)
- Failure to Calibrate
Patient
NO INFO
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE ACCOUNT STATED THE ARCHITECT LH QUALITY CONTROL SHIFTED HIGH AND OCCASIONALLY IS OUT OF RANGE. ALSO, AFTER CALIBRATION, THE ACCOUNT REC'D ERROR 1227, ASSAY (LH) NUMBER (Y) CALIBRATION FAILURE, FIT CONCENTRATION TOO HIGH FOR CAL F. NO RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO IMPACT TO PT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
INVESTIGATION CURRENTLY IN PROCESS. THIS ISSUE WAS IDENTIFIED WHILE INVESTIGATING AN INCREASE IN CUSTOMER COMPLAINTS FOR UPWARD SHIFTS IN NON-ABBOTT CONTROL AND PATIENT 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 WOULD 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