BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (RACK SYSTEM)

    MDR report key: 20832317 · Received December 3, 2024

    Report

    Report Number
    1823260-2024-03500
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    November 11, 2024
    Report Date
    December 13, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924721
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MEDICAL DEVICE PROBLEM, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSION CODES WERE UPDATED. CALIBRATION WAS LAST PERFORMED ON (B)(6) 2024 WITH ACCEPTABLE RESULTS. QC WAS ACCEPTABLE. THERE IS NO INDICATION OF A REAGENT PERFORMANCE ISSUE. MULTIPLE "VOLUME INSUFFICIENT" OR "CLOT PIPETTING" ALARMS WERE OBSERVED ON THE ALARM TRACE FROM THE DAY OF THE EVENT NEAR THE TIME THE SAMPLE WAS PROCESSED.

    Additional Manufacturer Narrative · 0

    THE ESTRADIOL III REAGENT LOT NUMBER WAS 792358. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) ADJUSTED THE MEASURING CELL VOLTAGE AND THE BLANK CELL CALIBRATION MEAN. BLANK CELL CALIBRATION PASSED WITH NO ISSUES. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED LOW RESULTS AFTER DILUTION FOR 1 PATIENT SAMPLE TESTED FOR ESTRADIOL III ON A COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT FROM THE PRIMARY TUBE WAS > 3000 PG/ML WITH A DATA FLAG. AN ALIQUOT FROM THE PRIMARY TUBE WAS RUN AND THE RESULT WAS > 3000 PG/ML WITH A DATA FLAG. THE PRIMARY TUBE WAS REPEATED WITH A 1:10 DILUTION AND THE RESULT WAS 2164 PG/ML. THE ALIQUOT WAS REPEATED WITH A 1:10 DILUTION AND THE RESULT WAS 2334 PG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543148 COBAS E 411 ANALYZER (RACK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924721

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female