BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (RACK SYSTEM)

    MDR report key: 21240661 · Received January 27, 2025

    Report

    Report Number
    1823260-2025-00232
    Event Type
    Malfunction
    Date Received
    January 27, 2025
    Date of Event
    January 6, 2025
    Report Date
    February 7, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924721
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HCG+BETA, FT3, AND B12 CALIBRATIONS AND QCS WERE ACCEPTABLE. THE FT3 AND B12 QCS WERE ACCEPTABLE. THE ALARM TRACE PROVIDED DID NOT INDICATE ANY ISSUES. BASED ON THE PROVIDED INFORMATION, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. A GENERAL REAGENT PROBLEM WAS NOT PRESENT, BECAUSE THE QC BEFORE THE EVENT WAS WITHIN RANGES.

    Additional Manufacturer Narrative · 0

    THE HCG+BETA REAGENT LOT NUMBER WAS 79772300 WITH AN EXPIRATION DATE OF 31-OCT-2025 THE FT3 REAGENT LOT NUMBER WAS 801917. THE EXPIRATION DATE WAS NOT PROVIDED. THE B12 REAGENT LOT NUMBER WAS 792322. THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS E411 RACK ANALYZER. SAMPLE 1 INITIAL ELECSYS HCG+BETA RESULT WAS 0.833 IU/L. THE PATIENT COMPLAINED AND THE SAME SAMPLE WAS REPEATED ON (B)(6) 2025 WITH A RESULT OF >10000 IU/L WITH A DATA FLAG. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT AS THE PATIENT WAS CONFIRMED TO BE PREGNANT. ON (B)(6) 2025, SAMPLE 2 INITIAL B12 RESULT WAS 36.90 PMOL/L WITH A DATA FLAG AND THE REPEAT RESULT WAS 430.3 PMOL/L. THE REPEAT RESULT WAS BELIEVED CORRECT AS IT MATCHED A REPEAT RESULT FROM A COBAS 8000 ANALYZER. NO SPECIFIC RESULT WAS PROVIDED. ON (B)(6) 2025, SAMPLE 3 INITIAL FT3 RESULT WAS 1.33 PMOL/L WITH A DATA FLAG AND THE REPEAT RESULT WAS 4.68 PMOL/L. THE REPEAT RESULT WAS BELIEVED CORRECT AS IT MATCHED A REPEAT RESULT FROM A COBAS 8000 ANALYZER. NO SPECIFIC RESULT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830414 COBAS E 411 ANALYZER (RACK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E 411 04015630924721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown