UNICEL® DXC 600 SYNCHRON® SYSTEM
Received Mar 28, 2012 · Event occurred Mar 2, 2012
Report 2050012-2012-00774 · MDR key 2508239
Device
Generic name
Analyzer, Chemistry
Manufacturer
Beckman Coulter, Inc.Model number
NACatalog number
A11810
Lot number
NA
Product problems
- High Test Results
Patient
3 DA
- No Code Available
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT ERRONEOUSLY ELEVATED TOTAL BILIRUBIN (TBIL) RESULTS WERE GENERATED FROM A UNICEL DXC 600 SYNCHRON SYSTEM FOR ONE PATIENT'S SAMPLE. THIS REPORT REPRESENTS THE ERRONEOUSLY ELEVATED TBIL RESULTS GENERATED FROM A UNICEL DXC 600 SYNCHRON SYSTEM ON (B)(6) 2012. THE INITIAL PATIENT SAMPLE WAS A HEMOLYZED HEEL-STICK SAMPLE RUN IN A SAMPLE CUP. THE ERRONEOUS, INITIAL TBIL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND THE PATIENT WAS TRANSPORTED AND ADMITTED TO A HOSPITAL FOR FOLLOW-UP TREATMENT BASED UPON THE TBIL RESULTS. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED PATIENT DATA INDICATED THAT THE PATIENT WAS REDRAWN AT THE HOSPITAL VIA VENIPUNCTURE AND RETESTED ON AN ALTERNATE INSTRUMENT. THE RESULTS WERE LOWER AND REGARDED AS VALID. THE PATIENT'S HISTORY AND CURRENT LABORATORY RESULTS DID NOT NOTE ANY PATIENT ABNORMALITIES, AND THE REDRAWN SAMPLE'S RESULTS WERE BELOW THE THRESHOLD FOR PHOTOTHERAPY. THE PATIENT WAS NOT TREATED AND WAS DISCHARGED. NO OTHER PATIENT SAMPLES WERE AFFECTED.
Additional Manufacturer Narrative
SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT AS IT WAS BELIEVED TO BE SAMPLE RELATED. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT/CHEMISTRY PERFORMANCE DATA INDICATED THAT TBIL CALIBRATION AND QUALITY CONTROL RESULTS HAD BEEN ACCEPTABLE. NO CUSTOMER MAINTENANCE WAS NEEDED, AND NO MAINTENANCE WAS PERFORMED SPECIFICALLY FOR THIS ISSUE. BECKMAN COULTER INC. CUSTOMER INFORMATION SHEETS INDICATE RED BLOOD CELL HEMOLYSATE AS A SOURCE OF INTERFERENCE; HOWEVER THE SPECIFIC PATIENT SAMPLE INVOLVED IN THIS EVENT WAS NOT INTERFERENCE TESTED AND HENCE THIS CANNOT BE CONFIRMED FOR THIS EVENT. THE BECKMAN COULTER INC. REPRESENTATIVE ADVISED THE CUSTOMER TO REJECT ALL HEMOLYZED NEONATAL HEEL STICK SAMPLES FOR TBIL. WHILE THE CAUSE MAY HAVE BEEN SAMPLE-SPECIFIC INTERFERENCE, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. ASSOCIATED MDRS: 2050012-2012-00774, 2050012-2012-00775.