BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (DISK SYSTEM)

    MDR report key: 21729669 · Received March 31, 2025

    Report

    Report Number
    1823260-2025-00935
    Event Type
    Malfunction
    Date Received
    March 31, 2025
    Date of Event
    November 22, 2024
    Report Date
    April 11, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630937103
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) IDENTIFIED CONTAMINATION IN THE LABORATORY WHERE DUST WAS COLLECTED FROM THE AIR CONDITION FLAPS ON THE INSTRUMENT SURFACE. GENERAL INSTRUMENT AND REAGENT ISSUES WERE NOT IDENTIFIED. THE LABORATORY WAS CLEANED. THE FSE DECONTAMINATED THE INSTRUMENT AND THEN DID A PERFORMANCE CHECK AND IT WAS WITHIN SPECIFICATIONS. THE CUSTOMER HAD TAKEN LOCAL MEASURES TO MINIMIZE/PREVENT RE-CONTAMINATION OF THE LABORATORY. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT WAS DUE TO ENVIRONMENTAL CONTAMINATION.

    Additional Manufacturer Narrative · 0

    THE E2 III REAGENT LOT NUMBERS USED WERE 792358 WITH AN EXPIRATION DATE OF 31-MAY-2025 AND 844594 WITH AN EXPIRATION DATE OF 31-JAN-2026. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 8 PATIENTS' SAMPLES TESTED WITH ELECSYS ESTRADIOL G3 (E2 III) ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER (DISK SYSTEM). SAMPLE 1 (PATIENT 1) WAS TESTED ON (B)(6) 2024: INITIAL RESULT: 1375.0 PG/ML. REPEAT RESULT: 169.7 PG/ML. SAMPLE 2 (PATIENT 2) WAS TESTED ON (B)(6) 2024: INITIAL RESULT: >3000 PG/ML. REPEAT RESULT: 99.83 PG/ML. SAMPLE 3 (PATIENT 3) WAS TESTED ON (B)(6) 2025: INITIAL RESULT: 1169.0 PG/ML. 1ST REPEAT RESULT: 101.6 PG/ML AND THIS RESULT WAS CONSIDERED TO BE CORRECT. 2ND REPEAT RESULT: 1178 PG/ML. 3RD REPEAT RESULT: 1617 PG/ML. SAMPLE 4 (PATIENT 4) WAS TESTED ON (B)(6) 2025: INITIAL RESULT: >3000 PG/ML. REPEAT RESULT: 410.4 PG/ML. SAMPLE 5 AND SAMPLE 6 WERE TESTED ON (B)(6) 2025: SAMPLE 5 (PATIENT 5): INITIAL RESULT: 78.7 PG/ML. REPEAT RESULT: 174.9 PG/ML AND THIS RESULT WAS CONSIDERED TO BE CORRECT. SAMPLE 6 (PATIENT 6): INITIAL RESULT: 3000 PG/ML. REPEAT RESULT: 561.2 PG/ML AND THIS RESULT WAS CONSIDERED TO BE CORRECT. SAMPLE 7 (PATIENT 7) WAS TESTED ON (B)(6) 2025: INITIAL RESULT: 2215 PG/ML. REPEAT RESULT: 211.0 PG/ML. SAMPLE 8 (PATIENT 8) WAS TESTED ON (B)(6) 2025: INITIAL RESULT: 711.7 PG/ML. REPEAT RESULT: 24.27 PG/ML. THE PHYSICIAN QUESTIONED THE INITIAL RESULTS AS THEY DID NOT MATCH THE PATIENTS' CLINICAL PICTURES, LH, AND ULTRASOUND RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165735 COBAS E 411 ANALYZER (DISK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630937103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown