BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (RACK SYSTEM)

    MDR report key: 20818639 · Received December 2, 2024

    Report

    Report Number
    1823260-2024-03477
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    November 1, 2024
    Report Date
    December 27, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924721
    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 CHECKED THE ANALYZER AND WAS UNABLE TO DETERMINE A CAUSE. HE PERFORMED PREVENTIVE MAINTENANCE AND FOUND THE REAGENT PACK IN QUESTION HAD A LOT OF BUBBLES. HE RAN PERFORMANCE TESTING THAT WAS SUCCESSFUL. AS THE QC RECOVERY WAS ACCEPTABLE, THERE WAS NO INDICATION OF A PERFORMANCE ISSUE WITH THE REAGENT OR INSTRUMENT. THE ANALYZER ALARM TRACE CONTAINED MULTIPLE SAMPLE SHORT AND SAMPLE CLOT/PIP DETECTION ALARMS ON THE DATE OF THE EVENT NEAR THE TIME THE SAMPLE WAS PROCESSED. THIS IS AN INDICATION OF POOR SAMPLE QUALITY. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER WAS 792358. THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III RESULTS FROM THE COBAS E411 RACK ANALYZER. THE INITIAL RESULT WAS 71 PG/ML. THE PHYSICIAN QUESTIONED THIS RESULT BASED ON THE PATIENT'S PREVIOUS HISTORY. THE REPEAT RESULT WAS 300 PG/ML. THIS RESULT WAS BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326835 COBAS E 411 ANALYZER (RACK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown