ELECSYS CMV IGG
Received Jul 15, 2025 · Event occurred Jun 19, 2025
Report 1823260-2025-02153 · MDR key 22508125
Device
Product problems
- Low Test Results
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE E801 ANALYZER IS (B)(6). SAMPLES FROM THE PATIENT WERE REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH ELECSYS CMV IGG ON A COBAS E 801 ANALYTICAL UNIT. THE FIRST SAMPLE INITIALLY RESULTED IN A CMV IGG VALUE OF 0.150 U/ML (NON-REACTIVE) AND IT REPEATED AS 0.150 U/ML (NON-REACTIVE). THE SAMPLE WAS TESTED IN ANOTHER LABORATORY USING A CMIA METHOD, RESULTING IN A CMV IGG VALUE OF 52.5 AIU/ML (POSITIVE) ON (B)(6) 2025. THE SECOND SAMPLE INITIALLY RESULTED IN A CMV IGG VALUE OF < 0.150 U/ML (NON-REACTIVE). THE SAMPLE WAS TESTED IN ANOTHER LABORATORY USING A CMIA METHOD, RESULTING IN A CMV IGG VALUE OF 9.10 AIU/ML (POSITIVE). THE THIRD SAMPLE INITIALLY RESULTED IN A CMV IGG VALUE OF < 0.150 U/ML (NON-REACTIVE). THE SAMPLE WAS TESTED IN ANOTHER LABORATORY USING A CMIA METHOD, RESULTING IN A CMV IGG VALUE OF 3.82 AIU/ML (POSITIVE). THE POSITIVE SAMPLE VALUES WERE DEEMED CORRECT.
Additional Manufacturer Narrative
THERE WAS NOT SUFFICIENT PATIENT MATERIAL LEFT FOR INVESTIGATION. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.