ELECSYS IGF-1

Additional Manufacturer Narrative

THE ROCHE AND SIEMENS METHODS ARE NOT COMPARABLE. INTERNAL INVESTIGATIONS DETERMINED A CALIBRATION ISSUE WITH THE ELECSYS IGF-1 ASSAY, LEADING TO ELEVATED RESULTS IN PATIENT SAMPLES WITH VERY HIGH IGF-1 CONCENTRATIONS (BETWEEN 800 NG/ML AND 1600 NG/ML). DILUTED RESULTS MORE ACCURATELY REFLECT THE TRUE IGF-1 CONCENTRATION. THERE WAS NO ISSUE WITH IGF-1 RESULTS <800 NG/ML. THE CALIBRATION ISSUE WAS CORRECTED, AND CUSTOMERS WERE ADVISED TO CHANGE TO THE NEW LOT NUMBERS 912807 AND 912815. HOWEVER, EVEN WITH THE NEW LOT NUMBERS, THE ROCHE RESULTS WOULD REMAIN DIFFERENT FROM THE SIEMENS RESULTS AS THE METHODS ARE NOT COMPARABLE.

Additional Manufacturer Narrative

THE E801 MODULE SERIAL NUMBER WAS (B)(6).

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF HIGH RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR ELECSYS IGF-1 (IGF-1) STARTING AT THE BEGINNING OF (B)(6) 2025 ON A COBAS 8000 E 801 MODULE. THE CUSTOMER HAD PREVIOUSLY USED THE IMMULITE INSTRUMENT, AND THE IGF-1 RESULTS WERE LOWER. AN EXAMPLE OF QUESTIONABLE RESULTS WAS PROVIDED FOR 1 PATIENT SAMPLE. ON (B)(6) 2025, THE RESULT FROM THE SIEMENS METHOD WAS 706.0 NG/ML. ON (B)(6) 2025, THE RESULT FROM THE E801 MODULE WAS 1107 NG/ML. THE REPEAT RESULT WAS 1153 NG/ML. THE PATIENT HAD A PREVIOUS RESULT (B)(6) 2025) FROM THE IMMULITE INSTRUMENT OF 673 NG/ML.