ELECSYS IGE II

Additional Manufacturer Narrative

IN THE INITIAL MEDWATCH, THE LAST LINE OF H11 ADDITIONAL NARRATIVE SHOULD HAVE BEEN: "THE FIFTH REPEAT RESULT USING AN ALIQUOT SAMPLE FROM THE CCM AT 20X DIRECT DILUTION USING A NEW REAGENT PACK WAS 4422 IU/ML." INSTEAD OF: "THE FIFTH REPEAT RESULT USING AN ALIQUOT SAMPLE FROM THE CCM AT 20X DIRECT DILUTION WAS 4422 IU/ML." THE INVESTIGATION REVIEWED THE CALIBRATION DATA. THE 23-NOV-2024 HAD CALIBRATOR 1 RESULTS SLIGHTLY BELOW THE SPECIFIED RANGES WHILE CALIBRATOR 2 WAS WITHIN THE SPECIFIED RANGES. THE 04-JAN-2025 CALIBRATION HAD RESULTS BELOW THE SPECIFIED RANGES. THE INVESTIGATION REVIEWED THE QC DATA. QC LEVELS 1 AND 3 WERE PERFORMED ON 31-JAN-2025 AND THE LAST QC PERFORMED FOR LEVEL 2 WAS ON 13-JAN-2025. THE THREE QC LEVELS WERE STABLE AND WITHIN THE SPECIFIED +/-3 STANDARD DEVIATION RANGE. THE INVESTIGATION REVIEWED THE CUSTOMER'S HANDLING OF PATIENT SAMPLES; NO ISSUES WERE NOTED. THE PATIENT SAMPLE IS INSUFFICIENT FOR INVESTIGATION. A GENERAL REAGENT ISSUE WAS NOT DETECTED. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S COBAS E 801 ANALYTICAL UNIT IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS IGE II RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. ON (B)(6)2025: THE INITIAL RESULT USING THE PRIMARY SAMPLE WAS 2430 IU/ML. THE FIRST REPEAT RESULT USING THE PRIMARY SAMPLE WAS 2500 IU/ML WITH A DATA FLAG. THE SECOND REPEAT RESULT USING THE PRIMARY SAMPLE AT 20X DIRECT DILUTION WITH 3 REMAINING TESTS IN THE REAGENT KIT WAS 4463 IU/ML. THE THIRD REPEAT RESULT USING AN ALIQUOT SAMPLE FROM THE COBAS CONNECTION MODULES (CCM) WITH ONE REMAINING TEST IS THE REAGENT KIT WAS 2333 IU/ML. THE FOURTH REPEAT RESULT USING AN ALIQUOT SAMPLE FROM THE CCM WITH A NEW REAGENT KIT AT 20X MANUAL DILUTION WAS 2421 IU/ML. THIS RESULT WAS REPORTED. ON (B)(6) 2025: THE FIELD APPLICATIONS SPECIALIST INVESTIGATED THE EVENT. THE FIFTH REPEAT RESULT USING AN ALIQUOT SAMPLE FROM THE CCM AT 20X DIRECT DILUTION WAS 4422 IU/ML.