ELECSYS VITAMIN B12 II

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S COBAS 6000 E601 MODULE IS (B)(6). THE 13-MAR-2025 CALIBRATION RESULTS WERE SLIGHTLY LOWER THAN THE SPECIFIED RANGES. THE 17-MAR-2025 QC LEVEL 2 RESULT WAS WITHIN THE SPECIFIED RANGE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS VITAMIN B12 IMMUNOASSAY RESULTS FROM FOUR PATIENT SAMPLES TESTED ON THE COBAS 6000 E601 MODULE. ON (B)(6) 2025: PATIENT SAMPLE 1 THE INITIAL RESULT WAS 158.7 PG/ML. THE REPEAT RESULT WAS 78.54 PG/ML. ON (B)(6) 2025: PATIENT SAMPLE 2 THE INITIAL RESULT WAS 122.4 PG/ML. THE REPEAT RESULT WAS 211.0 PG/ML. PATIENT SAMPLE 3 THE INITIAL RESULT WAS 170.2 PG/ML. THE REPEAT RESULT WAS 306.6 PG/ML. ON (B)(60 2025: PATIENT SAMPLE 4 THE INITIAL RESULT WAS 136.7 PG/ML. THE REPEAT RESULT WAS 261.8 PG/ML.

Additional Manufacturer Narrative

ON (B)(6) 2025, ADDITIONAL QUESTIONABLE ELECSYS VITAMIN B12 IMMUNOASSAY RESULTS WERE REPORTED: PATIENT SAMPLE 5 THE INITIAL RESULT WAS 136 PG/ML. THE FIRST REPEAT RESULT WAS 224.5 PG/ML. THE SECOND REPEAT RESULT WAS 238.5 PG/ML. THE THIRD REPEAT RESULT WAS 231.9 PG/ML. PATIENT SAMPLE 6 THE INITIAL RESULT WAS 164.7 PG/ML. THE FIRST REPEAT RESULT WAS 249.0 PG/ML. THE SECOND REPEAT RESULT WAS 251.3 PG/ML. THE THIRD REPEAT RESULT WAS 257.0 PG/ML. THE CALIBRATION RESULTS SHOWED THAT CALIBRATOR 2 HAD SLIGHTLY LOWER RESULTS THAN THE SPECIFIED RANGE. THE CUSTOMER STATED THAT THEY ONLY USED QC LEVEL 2 AND THEY DID NOT USE QC LEVEL 1 DURING THE DATE OF EVENT. THE (B)(6) 2025 QC TRACES SHOWED THAT THE LEVEL 2 QCS WERE WITHIN RANGE. THE QC GLOBAL RECOVERY OF THE REPORTED LOT WAS WITHIN RANGE. THE INVESTIGATION EXCLUDED A GLOBAL ISSUE. PRODUCT LABELING STATES, "QUALITY CONTROL - USE ELECSYS PRECICONTROL VARIA OR OTHER SUITABLE CONTROLS FOR ROUTINE QUALITY CONTROL PROCEDURES. CONTROLS FOR THE VARIOUS CONCENTRATION RANGES SHOULD BE RUN INDIVIDUALLY AT LEAST ONCE EVERY 24 HOURS WHEN THE TEST IS IN USE, ONCE PER REAGENT KIT, AND FOLLOWING EACH CALIBRATION." THE CUSTOMER USES A FIXED CENTRIFUGE, WHICH IS NOT RECOMMENDED AS IT AFFECTS SAMPLE QUALITY. THE FIELD APPLICATIONS SPECIALIST (FAS) INVESTIGATED THE EVENT AND FOUND THAT THE CUSTOMER USED THE WRONG CALIBRATION SET LOT FROM THE INSTALLED ONE. THE FAS INSTALLED THE CORRECT CALIBRATION SET, WHICH RESOLVED THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.