ELECSYS VITAMIN B12 II

Additional Manufacturer Narrative

THE INVESTIGATION NOTED THAT THE CALIBRATION SIGNALS PRIOR TO (B)(6)2023 WERE ON THE LOWER SIDE OR SLIGHTLY BELOW THE APPROXIMATE SIGNAL RANGES. ONE FAILED CALIBRATION WAS NOTED WHICH WAS CONSISTENT WITH A CALIBRATOR HANDLING ISSUE BECAUSE THE NEXT CALIBRATIONS WITH THE SAME REAGENT PACK WERE SUCCESSFUL. THE CUSTOMER PERFORMED A SUCCESSFUL CALIBRATION USING FRESH CALIBRATION MATERIAL ON (B)(6)2023. PRIOR TO THE CALIBRATION ON (B)(6)2023, THE QC RECOVERY WAS FLUCTUATING MAINLY BETWEEN THE TARGET VALUE AND -3 STANDARD DEVIATIONS (SD) INCLUDING ON THE DATE OF THE EVENT ( THE QC WAS CLOSE TO -2SD). THE QC WAS CLOSE TO THE TARGET AFTER THE (B)(6)-2023 CALIBRATION. THERE WERE NO ISSUES NOTED WITH THE CUSTOMER'S MEASURING CELL EXCHANGE AND LIQUID FLOW CLEANING (LFC). THE INVESTIGATION DETERMINED THAT THE ISSUE WAS CONSISTENT WITH A CALIBRATION/CALIBRATOR HANDLING ISSUE AT THE CUSTOMER SITE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE CALIBRATION PERFORMED ON (B)(6) 2022 SHOWED SIGNALS THAT WERE ROUGHLY WITHIN EXPECTATIONS BUT SLIGHTLY ON THE LOWER SIDE. THE CALIBRATION WAS NOTED TO BE VERY OLD (4 MONTHS). PRODUCT LABELING STATES "CALIBRATION FREQUENCY: RENEWED CALIBRATION IS RECOMMENDED AS FOLLOWS: AFTER 1 MONTH (28 DAYS) WHEN USING THE SAME REAGENT LOT AFTER 7 DAYS (WHEN USING THE SAME REAGENT KIT ON THE ANALYZER) AS REQUIRED: E.G. QUALITY CONTROL FINDINGS OUTSIDE THE DEFINED LIMITS." THE QC DATA SHOWED FLUCTUATIONS MAINLY BETWEEN THE TARGET AND -3 STANDARD DEVIATION (SD) AS PER THE IMAGE PROVIDED. THE QC 1 ON THE DATE OF THE EVENT WAS AROUND -2 SD. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS VITAMIN B12 II (VITAMIN B12 II) RESULTS FROM THE COBAS E411 DISK WITH SERIAL NUMBER (B)(4). THE REPORTER ALLEGED THAT TWO VITAMIN B12 II PATIENT RESULTS RECOVERED LOW. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT SAMPLES WERE RERUN ON THE ANALYZER. THEY WERE ALSO SENT TO A MAIN LABORATORY THAT USES AN E 801 FOR RERUNS. THE REPORTER WAS ADVISED TO RECALIBRATE USING A NEW REAGENT PACK. SAMPLE 1: THE INITIAL RESULT FROM THE ANALYZER WAS 103.4 PG/ML. THE FIRST REPEAT RESULT FROM THE ANALYZER WAS 151 PG/ML. THE SECOND REPEAT RESULT FROM THE E 801 WAS 201 PG/ML. SAMPLE 2: THE INITIAL RESULT FROM THE ANALYZER WAS 85.40 PG/ML. THE FIRST REPEAT RESULT FROM THE ANALYZER WAS 78 PG/ML. THE SECOND REPEAT RESULT FROM THE E 801 WAS 178 PG/ML. THE THIRD REPEAT RESULT FROM THE NEW AND RECALIBRATED REAGENT PACK USING AN ALIQUOT SAMPLE WAS 54 PG/ML.