ELECSYS TACROLIMUS

Additional Manufacturer Narrative

THE ROOT CAUSE REMAINS UNCLEAR AS NO SAMPLES WERE AVAILABLE TO INVESTIGATE FURTHER. THE LAST CALIBRATION WAS PERFORMED ON 10-MAY-2021 AND WAS ACCEPTABLE. THE QC DATA PROVIDED WAS ACCEPTABLE FOR LEVEL 2. LEVELS 1 AND 3 DO NOT COVER THE DAY OF THE EVENT. THIS WOULD RULE OUT A GENERAL REAGENT ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. MEDWATCH FIELD B7 HAS BEEN UPDATED.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TACROLIMUS RESULTS FOR THREE PATIENT SAMPLES WITH THE COBAS E411 IMMUNOASSAY ANALYZER SERIAL NUMBER (B)(4). THE REPORTER STATED THE E411 VALUES ARE LOWER AND NOT CORRELATING WHEN COMPARED TO A NEXUS CARE ANALYZER PERFORMED BY LIQUID CHROMATOGRAPHY WITH TANDEM MASS SPECTROMETRY (LC/MS/MS) VALUES WHICH ARE CORRELATING CLINICALLY. PATIENT A: ON (B)(6) , THE INITIAL RESULT WAS 2.68 NG/ML. ON (B)(6) 2021, THE REPEATED RESULT WAS 3.54 NG/ML. ON (B)(6) 2021, THE SECOND REPEATED RESULT WAS 3.0 NG/ML. ON (B)(6) 2021, THE LC/MS/MS RESULT WAS 15.25 MG/ML. PATIENT B: ON (B)(6) 2021, THE INITIAL RESULT WAS 1.4 NG/ML. ON (B)(6) 2021, THE REPEATED RESULT WAS 3.41 NG/ML. ON (B)(6) 2021, THE SECOND REPEATED RESULT WAS 4.5 NG/ML. ON (B)(6) 2021, THE LC/MS/MS RESULT WAS 10.27 NG/ML. PATIENT C: ON (B)(6) 2021, THE INITIAL RESULT WAS 2.96 NG/ML. ON (B)(6) 2021, THE REPEATED RESULT WAS 4.38 NG/ML. ON (B)(6) 2021, THE LC/MS/MS RESULT WAS 12.29 NG/ML. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.