IMMULITE 2000 IGF-I

Additional Manufacturer Narrative

SIEMENS FILE THE INITIAL MDR 1219913-2025-00200 ON 31-OCT-2025. ADDITIONAL INFORMATION (20-NOV-2025): AFTER REPLACING THE REAGENT PACK, CONTROL VALUES NORMALIZED. THE AFFECTED REAGENT PACK WAS NOT MADE AVAILABLE FOR INSPECTION. BETWEEN THE LAST QC FAILURE (OCTOBER 5.) AND RECOVERY (OCTOBER 6.), THE INSTRUMENT UNDERWENT SCHEDULED DECONTAMINATION. EVALUATION OF THE ANALYZER EVENT LOG DID NOT INDICATE ANY MECHANICAL OR PIPETTING ERRORS. THE FILES PROVIDED BY THE CUSTOMER CONTAIN NO PATIENT DATA, THEREFORE NO SAMPLE RESULTS COULD BE INVESTIGATED. THE ERROR LOG AND THE SPY FILES SHOW NO IRREGULARITIES FOR THE RELEVANT TIME PERIODS. BASED ON THE AVAILABLE INFORMATION PROVIDED, FURTHER EVALUATION IS NOT POSSIBLE, AND THE CAUSE OF THE ERRONEOUS RESULTS IS INCONCLUSIVE. SINCE REPLACEMENT OF THE REAGENT RESOLVED EVENT, IT CANNOT BE RULED OUT THAT A CONTAMINATED REAGENT LED TO A FAILURE IN QUALITY CONTROL AND THE ERRONEOUS PATIENT RESULTS. THE EVENT IS RESOLVED BY ROUTINE TROUBLESHOOTING BY CHANGING THE REAGENT. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

Description of Event or Problem

THE CUSTOMER CONTACTED SIEMENS AND REPORTED THAT FALSELY LOW INSULIN-LIKE GROWTH FACTOR-1 (IGF-1) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN IMMULITE 2000 XPI SYSTEM USING IMMULITE 2000 IGF-1 REAGENT (LOT 342). AFTER OBSERVING A QUALITY CONTROL (QC) NEGATIVE BIAS, THE CUSTOMER REPROCESSED THE PATIENT SAMPLES THE FOLLOWING DAY ON AN ALTERNATE IMMULITE 2000 XPI SYSTEM, AND THE IGF-1 RESULTS RECOVERED HIGHER. THE HIGHER IGF-1 RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW IGF-1 RESULTS.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). THE CALIBRATION IN EFFECT AT THE TIME OF PROCESSING HAD BEEN PERFORMED ON (B)(6) 2025, USING REAGENT LOT 342, AND WAS FOUND TO BE ADEQUATE ACCORDING TO THE INSTRUMENT'S HISTORICAL PERFORMANCE AND CONTROL RESULTS, WHICH REMAINED SATISFACTORY UNTIL THE FAILURE OBSERVED ON (B)(6) 2025. ON (B)(6) 2025, AT 21:00, BOTH LEVELS OF INTERNAL QUALITY CONTROL FAILED, SHOWING A NEGATIVE BIAS. A NEW RUN WAS PERFORMED USING ANOTHER ALIQUOT OF THE CONTROL MATERIAL, WHICH ALSO FAILED, MAINTAINING THE SAME BIAS PATTERN. CONTROL PERFORMANCE RETURNED TO ACCEPTABLE LEVELS AFTER REPLACEMENT OF THE REAGENT PACK. BETWEEN THE LAST CONTROL FAILURE (B)(6) 2025, AT 22:50) AND THE SUBSEQUENT APPROVAL (B)(6) 2025, AT 04:06), THE INSTRUMENT UNDERWENT ITS SCHEDULED MONTHLY DECONTAMINATION PROCEDURE. EVALUATION OF THE ANALYZER EVENT LOG DID NOT INDICATE ANY ERROR MESSAGES RELATED TO MECHANICAL FAILURES, PIPETTING ISSUES, OR THE PRESENCE OF FIBRIN/GEL. POSSIBLE CONTAMINATION OF THE REAGENT PACK IN USE AT THE TIME CANNOT BE RULED OUT AS A POTENTIAL CAUSE OF THE EVENT. SIEMENS IS INVESTIGATING.