OtherLTJ
AIA-PACK PA (PSA)
Received Jun 30, 2005 · Event occurred May 27, 2005
Report 2950409-2005-00028 · MDR key 743762
Device
Generic name
Prostate Specific Antigen Immunoassay
Manufacturer
Tosoh CorpModel number
NACatalog number
020263
Lot number
F111235
Product problems
- High Test Results
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
LABORATORY REPORTED A PSA RESULT OF 16.99. RESULT WAS QUESTIONED BY THE PHYSICIAN, REPEAT RESULT WAS <L (<0.05). PT WAS NOT TREATED BASED ON THE PSA RESULT OF 16.99. NO ADVERSE EVENT OCCURRED.