ELECSYS CMV IGM

Additional Manufacturer Narrative

THE COBAS E 801 MODULE SERIAL NUMBER WAS (B)(6). AS SUFFICIENT SAMPLE MATERIAL REMAINED, FURTHER INVESTIGATION WAS NOT POSSIBLE. THE INVESTIGATION WAS NOT ABLE TO DETERMINE A SPECIFIC ROOT CAUSE. NO PRODUCT PROBLEM WAS FOUND.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGM AND ELECSYS CMV IGG RESULTS FROM ONE PATIENT FROM THE COBAS E 801 MODULE. THIS MEDWATCH IS FOR THE ELECSYS CMV IGM ASSAY. REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS CMV IGG ASSAY. SAMPLE 1 (B)(6) 2025) AT 10 WEEKS OF PREGNANCY: THE ELECSYS CMV IGM RESULT WAS 0.38 COI WITH A DATA FLAG (NEGATIVE). THE ELECSYS CMV IGG RESULT WAS 0.150 U/ML WITH A DATA FLAG (NEGATIVE). ON (B)(6) 2025, THE DIASORIN LIAISON CMV IGM RESULT WAS 23.1 UA/ML (POSITIVE). THE DIASORIN LIAISON CMV IGG RESULT WAS 48 UA/ML (POSITIVE). THE DIASORIN LIAISON CMV IGG AVIDITY RESULT WAS 0.0493. THE VIDAS BIOMÉRIEUX CMV IGG RESULT WAS <6 UA/ML (GREYZONE/EQUIVOCAL). ON (B)(6) 2025, THE REPEAT ELECSYS CMV IGM RESULT USING REAGENT LOT 848029 WAS 0.40 COI (NEGATIVE). ELECSYS CMV IGG RESULT USING REAGENT LOT 836250 WAS 0.150 U/ML WITH A DATA FLAG (NEGATIVE). SAMPLE 2 (B)(6) 2025) 19 WEEKS OF PREGNANCY: THE ELECSYS CMV IGM RESULT WAS 2.72 COI. THE REPEAT RESULT WAS 2.67 COI (POSITIVE). THE ELECSYS CMV IGG RESULT WAS 10.8 U/ML. THE REPEAT RESULT WAS 10.6 U/ML (POSITIVE). ON (B)(6) 2025, THE DIASORIN LIAISON CMV IGM RESULT WAS 25.4 UA/ML (POSITIVE). THE DIASORIN LIAISON CMV IGG RESULT WAS 155 UA/ML (POSITIVE). THE DIASORIN LIAISON CMV IGG AVIDITY RESULT WAS 0.0797. THE VIDAS BIOMÉRIEUX CMV IGG RESULT WAS 43 UA/ML (POSITIVE). THE VIDAS BIOMÉRIEUX CMV IGG AVIDITY RESULT WAS 59 %. SAMPLE 3 (B)(6) 2025) 27 WEEKS OF PREGNANCY: ON (B)(6) 2025, THE DIASORIN LIAISON CMV IGM RESULT WAS 30.1 UA/ML (POSITIVE). THE DIASORIN LIAISON CMV IGG RESULT WAS 180 UA/ML (POSITIVE). THE DIASORIN LIAISON CMV IGG AVIDITY RESULT WAS 0.156. THE VIDAS BIOMÉRIEUX CMV IGG RESULT WAS 108 UA/ML (POSITIVE). THE VIDAS BIOMÉRIEUX CMV IGG AVIDITY RESULT WAS 74 %.