DSL 7800 ACTIVE CORTISOL
Received Nov 18, 2011 · Event occurred Jul 9, 2009
Report 1628193-2011-00005 · MDR key 2351738
Device
Product problems
- High Test Results
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
BECKMAN COULTER, INC. QUALITY ASSURANCE REPORTED ELEVATED CORTISOL RESULTS, FOR PT SERUM SAMPLES, INVOLVING DSL 7800 ACTIVE CORTISOL. THE ELEVATED RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE HAS BEEN NO REPORT OF PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THE LOT IN QUESTION.
Additional Manufacturer Narrative
INVESTIGATION WAS CONDUCTED TO STUDY BIAS FOR THE DSL (DIAGNOSTICS SYSTEMS LABORATORIES) CORTISOL EIA (ENZYME IMMUNOASSAY). THE ASSAY WAS NOT ANCHORED PROPERLY AND DRIFTED OVER TIME. THE PRODUCT HAS BEEN DISCONTINUED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM (B)(6) 2008 THROUGH (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS.
Remedial action
- Notification