ELECSYS BRAHMS PCT

Additional Manufacturer Narrative

IN THE INITIAL MDR, THE FIRST LINE OF B5 DESCRIBE EVENT OR PROBLEM SHOULD HAVE BEEN: "THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CALCITONIN RESULTS FROM SIX PATIENT SAMPLES TESTED ON THE COBAS 8000 CORE UNIT AND COBAS E 602 MODULE/S." INSTEAD OF: "THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CALCITONIN RESULTS FROM SIX PATIENT SAMPLES TESTED ON THE COBAS E 602 MODULE/S." THE SERIAL NUMBER OF THE COBAS 8000 CORE UNIT IS (B)(6). THE REAGENT PACKS WERE NOT PROVIDED FOR INVESTIGATION. THE INVESTIGATION NOTED THAT THE REPORTED REAGENT PACKS WERE NOT CALIBRATED OR RECALIBRATED. THE INVESTIGATION NOTED THAT THE QC WAS OUT OF RANGE (HIGH AND LOW). THE INVESTIGATION EXCLUDED A GENERAL REAGENT PROBLEM AS ANOTHER REAGENT PACK OF THE SAME LOT PERFORMED ACCORDING TO SPECIFICATIONS AT THE CUSTOMER¿S SITE. THE ISSUE WAS RESOLVED BY THE CUSTOMER'S USE OF ANOTHER REAGENT PACK OF THE SAME LOT. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH REAGENT KIT HANDLING, TRANSPORT, AND STORAGE; OR REAGENT KIT CONTAMINATION WITH PARTICLES OR FLUIDS AFTER LOCAL OPENING; OR DUE TO ENVIRONMENTAL CONDITIONS (STRONG MAGNETIC FIELDS) AND OTHER UNUSUAL CIRCUMSTANCES. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CALCITONIN RESULTS FROM SIX PATIENT SAMPLES TESTED ON THE COBAS E 602 MODULE/S. THE REPORTER ALSO COMPLAINED OF ERROR RESULTS IN QUALITY CONTROL (QC). ON (B)(6) 2024, THE REPORTER NOTED THAT DISCREPANT RESULTS WERE OBTAINED FROM THE SAME REAGENT PACK. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AS THEY DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSES ALERTING THEM TO AN ISSUE WITH THE RESULTS. SAMPLE 1 THE INITIAL RESULT WAS 13.12 NG/ML. THE REPEAT RESULT WAS 64.54 NG/ML. SAMPLE 2 THE INITIAL RESULT WAS 0.963 NG/ML. THE REPEAT RESULT WAS 0.241 NG/ML. ON (B)(6) 2024, QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER COMPLAINED THAT THIS WAS THE THIRD REAGENT PACK THAT GAVE DISCREPANT RESULTS. SAMPLE 3 THE INITIAL RESULT WAS 11.87 NG/ML. THE REPEAT RESULT WAS 0.235 NG/ML. SAMPLE 4 THE INITIAL RESULT WAS 10.96 NG/ML. THE REPEAT RESULT WAS 0.839 NG/ML. SAMPLE 5 THE INITIAL RESULT WAS 11.20 NG/ML. THE REPEAT RESULT WAS 40.91 NG/ML. SAMPLE 6 THE INITIAL RESULT WAS 11.42 NG/ML. THE REPEAT RESULT WAS 20.62 NG/ML.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S COBAS 8000 - COBAS E 602 MODULE USED ON (B)(6) 2024 WAS REQUESTED BUT NOT PROVIDED. THE SERIAL NUMBER OF THE CUSTOMER'S COBAS 8000 - COBAS E 602 MODULE USED ON (B)(6) 2024 IS 1945-10. THE THREE REAGENT PACKS WERE REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.