MalfunctionJJC
AIA-NEXIA TLA
Received Jun 7, 2005 · Event occurred May 12, 2005
Report 2950409-2005-00027 · MDR key 643758
Device
Generic name
Enzyme Immunoassay Analyzer
Manufacturer
Tosoh Corp.Model number
TLA, STOCKERCatalog number
018540
Lot number
NA
Product problems
- Incorrect Or Inadequate Test Results
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
CUSTOMER INDICATED THAT A PSA AND TSH RESULT WAS RELEASED BUT LAB WAS CONTACTED REGARDING THE PSA RESULT. PHYSICIAN INDICATED THAT THE PSA RESULT DID NOT MEET CLINICAL PICTURE. ORIGINAL RESULT: 16.0 NG/ML; REPEAT RESULT: 1.0 NG/ML.