OtherJJC
AIA-600II
Received Oct 11, 2006 · Event occurred Aug 30, 2006
Report 3005529799-2006-00002 · MDR key 971416
Device
Generic name
Automated Immunoassay System
Manufacturer
Tosoh Corp.Model number
AIA-600IICatalog number
019328
Lot number
*
Product problems
- Failure to Calibrate
- Incorrect Or Inadequate Test Results
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED TO TOSOH THAT A PT WAS TESTED FOR CNTL AT 10 AM ON 8/30 THE RESULT WAS 3.98. THIS RESULT WAS REPORTED. LATER THAT SAME DAY AT 4PM, 6 HRS LATER, THE PT WAS RE-DRAWN AND THE RESULT WAS NOW <0.06. THE LAB THEN WENT AND GOT THE ORIGINAL 10 AM PT SAMPLE AND RE-RAN IT. THE RESULT WAS NOW <0.06 ON THE REPEAT. THIS PT ALSO HAD A MB RUN AT 10 AM ON THE SAME SAMPLE AND THE RESULT WAS 5.2. THE 4 PM SAMPLE HAD A MB RUN AND THE RESULT WAS 2.3. NO PT INJURY REPORTED.