IMMULITE 2000

Description of Event or Problem

A DISCORDANT LOW (FALSE NEGATIVE) CMV IGG (CYTOMEGALOVIRUS IGG) RESULT WAS OBTAINED WITH ONE (1) PATIENT SAMPLE ON AN IMMULITE 2000 ANALYZER. THE DISCORDANT RESULT WAS RELEASED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE NEGATIVE RESULT DUE TO THE PATIENT'S HISTORY. A NEW SAMPLE WAS DRAWN AND TESTED, AND CORRECTED RESULTS WERE REPORTED. PATIENT CARE WAS NOT ALTERED OR PRESCRIBED DUE TO THE DISCORDANT CMV IGG RESULT. THERE WAS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CMV IGG RESULT.

Additional Manufacturer Narrative

A SIEMENS HEALTHCARE DIAGNOSTICS TECHNICAL SERVICE ENGINEER (TSE) ANALYZED THE INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT DATA SHOWED THAT THE CMV IGG LOT 268 KIT ADJUSTMENT PERFORMED ON (B)(6) 2011 WAS NOT VALIDATED BY THE OPERATOR. THE CUSTOMER CONFIRMED THAT THE TECHNICIAN WHO PERFORMED THE (B)(6) 2011 KIT ADJUSTMENT MADE AN ERROR WHEN RUNNING THE CVGPOS CONTROL. THE CUSTOMER ALSO NOTED THAT THE TECHNICIAN WHO PERFORMED THE ADJUSTMENT WAS INEXPERIENCED, AND DID NOT NOTICE THAT THE CVGPOS CONTROL VALUES WERE OUT OF RANGE (LOW). THE TECHNICIAN DID NOT REALIZE THE ADJUSTMENT WAS NOT VALID AND RAN THE PATIENT'S SAMPLE, IN SPITE OF THE CONTROL RESULTS FOR THAT DAY REFLECTING THAT THE ADJUSTMENT WAS PROBLEMATIC. A REPEAT KIT ADJUSTMENT FOR CMV IGG LOT 268 WAS SUCCESSFULLY PERFORMED BY ANOTHER TECHNICIAN ON (B)(6) 2011. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE INSTRUMENT IS REQUIRED.