DSL 7800 ACTIVE CORTISOL
Received Oct 7, 2011 · Event occurred Jun 9, 2009
Report 1628193-2011-00003 · MDR key 2320067
Device
Product problems
- High Test Results
Patient
NA
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A BECKMAN COULTER REPRESENTATIVE, WITHIN QUALITY CONTROL, REPORTED ELEVATED CORTISOL RESULTS FOR TRUE SAMPLES AND CONTROLS INVOLVING DSL 7800 ACTIVE CORTISOL. THE ELEVATED RESULTS DID NOT CORRELATE WITH ALTERNATE METHODOLOGIES. THERE WAS NO PATIENT IMPACT. THERE WAS NO PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.
Additional Manufacturer Narrative
INVESTIGATION CONFIRMED DSL-10-2000 PRODUCED RESULTS 2 TO 4 TIMES HIGHER COMPARED TO OTHER TEST ANALYSES. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM JANUARY 01, 2008 THROUGH OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.
Remedial action
- Notification