BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (DISK SYSTEM)

    MDR report key: 21856918 · Received April 17, 2025

    Report

    Report Number
    1823260-2025-01164
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    March 25, 2025
    Report Date
    May 5, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630937103
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER FOUND THE CAUSE WAS DUE TO A CRACKED SIPPER SYRINGE HOLDER (COMPONENT FAILURE). THE SERVICE ACTIONS PERFORMED BY THE ENGINEER RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT.

    Additional Manufacturer Narrative · 0

    THE HCG+B REAGENT LOT NUMBER WAS 77493005 WITH AN EXPIRATION DATE OF 30-JUN-2025. THE E2 III REAGENT LOT NUMBER WAS 79235803 WITH AN EXPIRATION DATE OF 31-MAY-2025. QC WAS ACCEPTABLE ON THE DAY OF THE EVENT. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE SIPPER SYRINGE HOLDER WAS CRACKED AND THE SIPPER PROBE WAS DRIPPING WATER. HE REPLACED THE SYRINGE SEALS AND THE PINCH TUBINGS. HE THEN PERFORMED LIQUID FLOW CLEANING AND CLEANED ALL PROBES, RINSE STATIONS, MIXING PADDLE, AND BUILT-UP CRUSTS. THE FSE THEN RAN MULTIPLE PRIMES AND SYSTEM VOLUME CHECKS, CHECKED THE VOLTAGE MONITOR, AND PERFORMED MEASURING CELL PREPARATIONS AND THEY WERE ALL WITHIN SPECIFICATIONS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS ESTRADIOL G3 (E2 III) ASSAY AND ELECSYS HCG+BETA (HCG+B) ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER (DISK SYSTEM). E2 III: INITIAL RESULT: 46.22 PG/ML. REPEAT RESULT: 1555 PG/ML (TESTED ON ANOTHER ANALYZER). HCG+B: INITIAL RESULT: <0.1 MIU/ML. 1ST REPEAT RESULT: <0.1 MIU/ML. 2ND AND 3RD REPEAT RESULTS WERE BOTH >10,000 MIU/ML AND ACCOMPANIED BY DATA FLAGS. 4TH REPEAT RESULT: 155078 MIU/ML (TESTED ON ANOTHER ANALYZER WITH A DILUTION FACTOR OF 1:100). 5TH REPEAT RESULT: 153213 MIU/ML (TESTED ON ANOTHER ANALYZER WITH A DILUTION FACTOR OF 1:100). THE PHYSICIAN QUESTIONED THE INITIAL RESULTS AS THE PATIENT WAS PREGNANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32678 COBAS E 411 ANALYZER (DISK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E 411 04015630937103

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female