IMMULITE 2000

Description of Event or Problem

DISCORDANT PROGESTERONE (PRG) RESULTS WERE OBTAINED ON FOURTEEN PATIENT SAMPLES ON AN IMMULITE 2000 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT, RESULTING HIGHER THAN THE INITIAL RESULTS EXCEPT FOR PATIENT 88138, WHICH RESULTED LOWER. THE REPEAT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROGESTERONE RESULTS.

Additional Manufacturer Narrative

A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE INSTRUMENT DATA. THE CAUSE OF DISCORDANT PROGESTERONE RESULTS ON FOURTEEN PATIENT SAMPLES IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE ISSUE.

Additional Manufacturer Narrative

THE INITIAL MDR 2247117-2015-00006 WAS FILED ON FEBRUARY 20, 2015. ADDITIONAL INFORMATION (04/21/2015): THE FALSELY LOW PROGESTERONE RESULTS OBSERVED BY THE CUSTOMER WAS INVESTIGATED AND IT WAS DETERMINED THAT THE SAMPLE COLLECTION TUBE TYPE WAS IMPACTING THE PROGESTERONE RESULTS. THE CUSTOMER WAS USING GEL BARRIER TUBES, WHICH IS AN OFF-LABEL USE. THE IMMULITE 2000 PROGESTERONE INSTRUCTIONS FOR USE STATES THAT "TIME-DEPENDENT DECREASES IN PROGESTERONE LEVELS HAVE BEEN REPORTED WHEN SERUM SAMPLES ARE COLLECTED AND STORED IN GEL BARRIER TUBES". THE CUSTOMER PERFORMED PROFICIENCY TESTING USING AN ALTERNATE SAMPLE COLLECTION TUBE TYPE, WHICH WAS ACCEPTABLE. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) SPECIALIST PROACTIVELY TIGHTENED THE DUAL RESOLUTION DILUTOR (DRD) NUT AND REPLACED THE REAGENT AND THE SAMPLE PROBES. THE INSTRUMENT IS PERFORMING ACCORDING TO THE SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.