UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
Received Sep 23, 2011 · Event occurred Apr 9, 2009
Report 2122870-2011-03977 · MDR key 2274008
Device
Product problems
- Incorrect Or Inadequate Test Results
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
AN INTERNATIONAL BECKMAN COULTER REP REPORTED ERRONEOUS CYTOMEGALOVIRUS (CMV) G ANTIBODY FOR PTS' AND QUALITY CONTROL RESULTS INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. WHEN THE ERRONEOUS RESULTS WERE TRANSMITTED TO AN ALTERNATE DXC SYSTEM SCREEN, RESULTS WERE NORMAL. THE INTERNATIONAL REP REBOOTED THE SYSTEM, BUT IT DID NOT RESOLVE THE ISSUE. IT IS UNK IF PTS WERE IMPACTED. THERE AHS BEEN NO REPORT OF PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT.
Additional Manufacturer Narrative
THERE IS NO INDICATION SERVICE WAS DISPATCHED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM JAN 1, 2008 THROUGH OCT 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.
Remedial action
- Notification