ARCHITECH LH
Received Dec 7, 2006 · Event occurred Aug 7, 2006
Report 1415939-2006-00052 · MDR key 795539
Device
Generic name
Cmia For The Quantitative Determination Of Human Luteinizing
Manufacturer
Abbott LaboratoriesModel number
NACatalog number
6C25-21
Lot number
33198M200
Product problems
- Use of Incorrect Control/Treatment Settings
- Other (for use when an appropriate device code cannot be identified)
- High Test Results
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER STATES THAT THEY NOTICED A SHIFT IN THE SAME PATIENT RESULTS THAT WERE HIGHER WHEN USING THE ARCHITECT LH ASSAY LOT 33198M200 THAN WITH THE FORMER LOT 32429M200. THE CUSTOMER ALSO NOTED A SHIFT IN CONTROL VALUES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
THIS ISSUE WAS IDENTIFIED WHILE INVESTIGATING AN INCREASE IN CUSTOMER COMPLAINTS FOR UPWARD SHIFTS IN NON-ABBOTT CONTROLS AND PATIENT SAMPLES, AS WELL AS CALIBRATION ERRORS. SPECIFICALLY, ERROR CODE 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. ABBOTT HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS RELATED TO THE AFFECTED LOTS OF ARCHITECT LH REAGENTS. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Remedial action
- Recall