IMMULITE 2000 ANDROSTENEDIONE

Additional Manufacturer Narrative

SIEMENS HAS OBSERVED OVER-RECOVERY IN THE IMMULITE/IMMULITE 1000/IMMULITE 2000 ANDROSTENEDIONE ASSAY FOR SAMPLES ACROSS THE ASSAYS' REPORTABLE RANGE OF 0.3-10 NG/ML (1.1-35 NMOL/L). SIEMENS HAS CONFIRMED THAT THE ISSUE NOTED IN THE DECEMBER 2013 FIELD ACTION IS NOT LIMITED TO ONLY SAMPLES >5.5 NG/ML (19.2 NMOL/L). SIEMENS HAS IDENTIFIED THAT THE ROOT CAUSE OF THE OVER-RECOVERY IS RELATED TO THE VARIABILITY OF A CRITICAL RAW MATERIAL. THIS ISSUE HAS BEEN RESOLVED BEGINNING WITH IMMULITE/IMMULITE 1000 KIT LOT 431, AND FOR IMMULITE 2000 BEGINNING WITH KIT LOT 331. AN URGENT FIELD SAFETY NOTICE (UFSN) 1113 FOR IMMULITE/IMMULITE 1000 AND UFSN 3021 FOR IMMULITE 2000 WAS SENT TO OUS CUSTOMERS IN NOVEMBER OF 2014. THE UFSN RECOMMENDS THAT THE CUSTOMER DISCARD THE AFFECTED KIT LOTS AND TO REVIEW THE LETTER WITH THEIR MEDICAL DIRECTOR.

Description of Event or Problem

THE CUSTOMER HAS REQUESTED ADDITIONAL INFORMATION REGARDING REFERENCE VALUES OTHER THAN THE ONES PROVIDED IN THE INSTRUCTIONS FOR USE (IFU) FOR THE ANDROSTENEDIONE ASSAY ON THE IMMULITE 2000 INSTRUMENT. THE REFERENCE RANGES PROVIDED IN THE CUSTOMER BULLETIN 2011-10-03 DO NOT MATCH THE RANGES PROVIDED IN THE IFU. IT IS UNKNOWN IF ANY RESULTS ARE BEING REPORTED TO THE PHYSICIAN(S). THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES REPORTED.