BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 19987325 · Received August 14, 2024

    Report

    Report Number
    1823260-2024-02363
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    June 18, 2024
    Report Date
    August 14, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBERS AND THEIR EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE MODULE AND DETERMINED THAT A HOLE IN THE ASPIRATION TUBE ON THE RINSE MECHANISM NOZZLE HAD CAUSED THE EVENT. THE FSE THEN REPLACED ALL OF THE RINSE MECHANISM TUBES. HE ALSO ADJUSTED THE GEAR PUMP PRESSURE. HE PERFORMED PRECISION CHECKS WITH ACCEPTABLE RESULTS. THE CUSTOMER PERFORMED QC WITH ACCEPTABLE RESULTS. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE HDL AND HBA1C ASSAY RESULTS FROM FORTY PATIENT SAMPLES TESTED ON THE COBAS 6000 C501 MODULE. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. A LABORATORY INVESTIGATION PROMPTED THE PATIENT SAMPLE RERUN. PLEASE REFER TO THE ATTACHMENT PT-0070531 FOR THE TABLE CONTAINING THE EXAMPLES OF PATIENT SAMPLES WITH DISCREPANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639581 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown