1- IMMULITE 2000 UNCONJUGATED ESTRIOL (UE3)

Additional Manufacturer Narrative

AN OUTSIDE THE UNITED STATES CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SUPPORT CENTER (RSC) REGARDING TWO FALSELY DEPRESSED PATIENT RESULTS WITH IMMULITE 2000 UNCONJUGATED ESTRIOL (UE3) THE INSTRUMENT IS AN IMMULITE® 2000 XPI IMMUNOASSAY SYSTEM. QUALITY CONTROL (QC) RECOVERED WITHIN RANGE. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATES: "FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THIS ASSAY SHOULD ALWAYS BE USED IN COMBINATION WITH THE CLINICAL EXAMINATION, PATIENT MEDICAL HISTORY, AND OTHER FINDINGS." SIEMENS IS INVESTIGATING.

Description of Event or Problem

THE CUSTOMER REPORTED THAT ON (B)(6) 2024 TWO FALSELY DEPRESSED PATIENT RESULTS, COMPARED TO REPEAT TESTING, WERE OBTAINED WITH UNCONJUGATED ESTRIOL (UE3), LOT NUMBER: 512. THE INSTRUMENT IS AN IMMULITE® 2000 XPI IMMUNOASSAY SYSTEM, SERIAL NUMBER: (B)(6) . THE INITIAL PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPROCESSED ON AN ALTERNATE IMMULITE® 2000 XPI SYSTEM SERIAL NUMBER: (B)(6) . THE HIGHER RESULTS WERE REPORTED AND CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ISSUE.

Additional Manufacturer Narrative

CORRECTION - JULY 31-2024. D4 WAS UPDATED TO REFLECT THE COMPLETE UDI. ADDITIONAL INFORMATION - JULY 11, 2024. UPON FURTHER REVIEW OF THE DATA, IT WAS IDENTIFIED THAT THE REPEAT RESULTS WERE GENERATED WITH IMMULITE 2000 XPI UE3 KIT LOT 509. SIEMENS PERFORMED A STUDY WHICH ASSESSED PATIENT SAMPLES ACROSS KIT LOTS 509, 511 AND 512 USING 509 AS THE REFERENCE LOT FOR THE ANALYSIS. THE AVERAGE BIAS BETWEEN LOTS WAS WITHIN EXPECTED PERFORMANCE AND DID NOT CONFIRM A NEGATIVE BIAS AND BETWEEN KIT LOTS. THE AVERAGE BIAS WAS <10% AND A NEGATIVE BIAS WAS NOT OBSERVED AS REPORTED BY THE CUSTOMER. THE QC QUALITY CONTROL RESULTS REPORTED WITHIN THE ASSIGNED QC GATES AND VALIDATED THE ASSAY. ADDITIONALLY, SIEMENS REVIEWED INTERNAL PANEL DATA. THIS PATIENT PANEL CONSISTS OF 60 PATIENT SAMPLES AND THESE SAMPLES INCLUDE NORMAL FEMALE SAMPLES AND SECOND TRIMESTER PREGNANCY SAMPLES. THE PATIENT PANEL IS KEPT CONSISTENT ACROSS KIT LOT RELEASES. EACH OF THE KITS RELEASED WERE TESTED ON THE SAME PATIENT PANEL AND PASSED THE LOT TO LOT METHOD COMPARISON CRITERIA. USING HISTOGRAM AND BOXPLOTS TO ASSESS THE PATIENT PANEL DISTRIBUTION, THERE WAS NO OBSERVED NEGATIVE SHIFTS IN THE DATA ACROSS THESE LOTS AND EACH KIT LOT WAS STATISTICALLY COMPARABLE. SIEMENS DID NOT REPLICATE THE CUSTOMER OBSERVATIONS OF A NEGATIVE SHIFT WITH KIT LOT 512 COMPARED TO KIT LOT 509. BASED ON THE ASSESSMENT; THE CAUSE OF THE DISCORDANT RESULT IS CONSISTENT WITH PREANALYTICAL VARIABLES. THE CUSTOMER IS OPERATIONAL.

Additional Manufacturer Narrative

INITIAL MDR 1219913-2024-00293 WAS FILED ON 23-APR-2024. ADDITIONAL INFORMATION - JUNE 5, 2024 SIEMENS REVIEWED ERROR LOGS AND MAIN DATA WITH REGARD TO PROCESS ERRORS. THE DATA SHOWS NO ISSUES WITH THE OPERATION OF THE SYSTEM ON THE DAY IN QUESTION. THE SAMPLE WAS RETESTED ON ANOTHER IMMULITE 2000 SYSTEM FOR TROUBLESHOOTING. THE RESULTS WERE HIGHER AND EXPECTED. THE SAMPLE IS NOT AVAILABLE TO BE SENT TO SIEMENS FOR TESTING. BASED ON THE ASSESSMENT; THE CAUSE OF THE DISCORDANT RESULT IS CONSISTENT WITH PREANALYTICAL VARIABLES. THE CUSTOMER IS OPERATIONAL. ISSUE RESOLVED VIA ROUTINE TROUBLESHOOTING. THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION CODES HAVE BEEN UPDATED IN SECTION H6.