ELECSYS CMV IGG

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE E 602 ANALYZER IS (B)(6). THE ELECSYS CMV IGG REAGENT LOT NUMBER AND EXPIRATION DATE USED ON 04-MAY-2024 IS NOT KNOWN. ELECSYS CMV IGG REAGENT LOT NUMBER 743314 (EXPIRATION DATE = UNKNOWN) WAS IN USE FROM (B)(6) 2024. ELECSYS CMV IGG REAGENT LOT NUMBER 772241 (EXPIRATION DATE = UNKNOWN) WAS IN USE FROM (B)(6) 2024 TO THE CURRENT DATE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE NEGATIVE RESULTS FOR THREE SAMPLES COLLECTED FROM THE SAME PATIENT TESTED WITH ELECSYS CMV IGG ON A COBAS 8000 E 602 MODULE. THE SPECIFIC DATE OF THE EVENT IS NOT KNOWN. THE FIRST SAMPLE WAS COLLECTED ON (B)(6) 2024 AND RESULTED IN AN ELECSYS CMV IGG VALUE OF < 0.15 U/ML (NON-REACTIVE) ON (B)(6) 2024. THIS SAMPLE WAS REPEATED USING THE ELFA METHOD ON (B)(6) 2024, RESULTING IN A CMV IGG VALUE OF 10 UI/ML (POSITIVE). THE SECOND SAMPLE WAS COLLECTED FROM THE PATIENT ON AN UNKNOWN DATE IN (B)(6) 2024 RESULTING IN AN ELECSYS CMV IGG VALUE OF < 0.15 U/ML (NON-REACTIVE). A THIRD SAMPLE COLLECTED FROM THE PATIENT AT ANOTHER SITE ON (B)(6) 2024 WAS TESTED USING AN UNKNOWN CHEMILUMINESCENCE METHOD, RESULTING IN A CMV IGG VALUE OF 19.50 AU/ML (REACTIVE). A FOURTH SAMPLE WAS COLLECTED FROM THE PATIENT ON (B)(6) 2024, RESULTING IN AN ELECSYS CMV IGG VALUE OF < 0.15 U/ML (NON-REACTIVE). THIS SAMPLE WAS REPEATED USING THE ELFA METHOD ON (B)(6) 2024, RESULTING IN A CMV IGG VALUE OF 8 UI/ML (POSITIVE).

Additional Manufacturer Narrative

ACCORDING TO THE DATA, THE CUSTOMER RAN THE SAMPLES FROM ON (B)(6) 2024 USING LOT: 743314 AND THE SAMPLE FROM ON (B)(6) 2024 WITH LOT NUMBER: 772241. CALIBRATION SIGNALS FOR LOT: 743314 FROM ON (B)(6) 2024 WAS FOUND WITHIN SPECIFIED RANGES. THE LAST RELEVANT CALIBRATION PERFORMED PRIOR TO THE SAMPLE MEASUREMENT IN AUGUST WAS PERFORMED ON (B)(6) 2024, EXCEEDING THE RECOMMENDED CALIBRATION FREQUENCY. ONLY ONE LEVEL OF CONTROLS WAS RUN ON (B)(6) 2024 FOR THE SAMPLE FROM ON (B)(6) 2024 AND WAS WITHIN THE SPECIFIED RANGE. NO QC DATA WAS AVAILABLE FOR THE SAMPLE FROM ON (B)(6) 2024 AND THE SAMPLE MEASUREMENT ON (B)(6) 2024. ACCORDING TO ANALYZER DATA, THE CUSTOMER APPEARS TO RUN QC ONLY EVERY TWO WEEKS, ALTERNATING EACH LEVEL OF CONTROL. THE PATIENT SAMPLES FROM ON (B)(6) 2024 WERE PROVIDED FOR INVESTIGATION. ALL PROVIDED SAMPLES WERE NON-REACTIVE FOR ELECSYS CMV IGM AND ELECSYS CMV IGG. WHEN TESTED USING RECOMLINE CMV IGG, ALL SAMPLES WERE NEGATIVE. THE RESULTS OBTAINED BY THE CUSTOMER COULD BE DUPLICATED. THE INVESTIGATION DETERMINED THE PATIENT IS SERONEGATIVE FOR CMV. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE.