BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 ISE 1800 MODULE

    MDR report key: 21663661 · Received March 21, 2025

    Report

    Report Number
    1823260-2025-00826
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    March 2, 2025
    Report Date
    April 25, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION AND CONTROLS WERE ACCEPTABLE. THERE WAS NO INDICATION OF A REAGENT PERFORMANCE ISSUE. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE K ELECTRODE LOT NUMBER WAS BJQ, WITH AN EXPIRATION DATE OF 25-NOV-2025. THE FIELD SERVICE ENGINEER COULD NOT REPRODUCE THE ISSUE. THE ANALYZER WAS INSPECTED AND PRECISION STUDIES WERE PERFORMED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 7 PATIENT SAMPLES TESTED WITH THE K ELECTRODE ON A COBAS 8000 ISE MODULE. THE CUSTOMER PROVIDED AN EXAMPLE OF ONE PATIENT SAMPLE WITH DISCREPANT K RESULTS. THE CUSTOMER STATED THEY WERE RE-CHECKING PATIENT SAMPLES DUE TO A QUALITY CONTROL OUTAGE FOR A CLINICAL CHEMISTRY TEST ON A DIFFERENT ANALYZER. AFTER REPEATING THE COMPLAINED SAMPLE, THE CUSTOMER NOTICED A DISCREPANCY IN THE K VALUES. THE SAMPLE INITIALLY RESULTED IN A K VALUE OF 3.86 MMOL/L. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 4.90 MMOL/L. THE REPEAT VALUE WAS DEEMED CORRECT BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641787 COBAS 8000 ISE 1800 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown