BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 21273157 · Received January 30, 2025

    Report

    Report Number
    1823260-2025-00279
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    January 7, 2025
    Report Date
    May 8, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AAT REAGENT LOT NUMBER WAS 792221 WITH AN EXPIRATION DATE OF 28-FEB-2026.

    Additional Manufacturer Narrative · 0

    THE RESULTS FROM THE HARDWARE CHECK SUGGEST ISSUES WITH THE ALIGNMENT OF MIXERS AND THE PHOTOMETRIC PATHWAY. THE FIELD SERVICE ENGINEER (FSE) ADDRESSED THE ISSUES IDENTIFIED FROM THE HARDWARE CHECK. THE ASSAY PERFORMED AS EXPECTED. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A WEAR PROBLEM AND ADJUSTMENT/ALIGNMENT ISSUES, HOWEVER, THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED THE RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR TINA-QUANT ALPHA-1 ANTITRYPSIN (AAT) ON A COBAS 8000 C 702 MODULE. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS FOR 2 PATIENT SAMPLES. PATIENT 1 INITIAL RESULT WAS 0.35 G/L. THE REPEAT RESULT FROM AN ALIQUOT OF THE SAMPLE WAS 1.51 G/L. PATIENT 2 INITIAL RESULT WAS 1.02 G/L. THE REPEAT RESULT FROM AN ALIQUOT OF THE SAMPLE WAS 0.43 G/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578408 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown