DSL-10-2000 ACTIVE® CORTISOL ENZYME IMMUNOASSAY (EIA) KIT
Received Jul 21, 2009 · Event occurred Jul 9, 2009
Report 1628193-2009-00001 · MDR key 1416817
Device
Generic name
Active® Cortisol Eia, 96 Wells
Manufacturer
Beckman Coulter Inc.Model number
NACatalog number
DSL-10-2000
Product problems
- High Test Results
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
DURING AN INTERNAL TESTING CONDUCTED BY BECKMAN COULTER INC. (BCI), IT WAS REPORTED THAT FALSE HIGH CORTISOL VALUES WERE GENERATED BY THE DSL-10-2000 ACTIVE CORTISOL ENZYME IMMUNOASSAY (EIA) KIT. BECKMAN COULTER HAS CONFIRMED THAT THE FOLLOWING LOT NUMBERS: 04195, 04195A, 04195B, 04195D, 04195E, 04195F, 09266A, 09266, 04126A, 04126, 03066A, 03066, 01036, 716217, 716218, 800408, 800409, 800410, 890929 AND 990168 OF ACTIVE CORTISOL ELISA CALIBRATORS OVER ESTIMATE THE EXPECTED DOSE VALUES FOR PATIENT SERUM SAMPLES DUE TO A SHIFT IN THE ASSIGNED CALIBRATOR VALUES. AN EXAMPLE FOR LOT 990168 WHICH YIELDED VALUES SIGNIFICANTLY ABOVE (2-5X) OTHER PRODUCTS. ALL KITS WITH AFFECTED LOTS RESULTED IN OVERESTIMATION OF CORTISOL DOSE. PATIENT RESULTS WERE NOT GENERATED IN THIS EVENT SINCE THE EVENT WAS DISCOVERED IN-HOUSE AND NO PATIENT SAMPLES WERE TESTED AT THE TIME. THERE WAS NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
ROOT CAUSE OF THE SHIFT IN THE CALIBRATION OF THE ASSIGNED STANDARD VALUES IS CURRENTLY UNDER INVESTIGATION. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.