BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 19059828 · Received April 8, 2024

    Report

    Report Number
    1823260-2024-01065
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    March 18, 2024
    Report Date
    April 8, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 760784. THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION EXCLUDED REAGENT ISSUES AS NO FURTHER CASES WERE REPORTED AND A CORRECT RERUN WAS PERFORMED WITH THE SAME REAGENT. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE MODULE, CHANGED THE PIPETTOR ASSEMBLIES, AND PERFORMED READJUSTMENTS. HE CONFIRMED THAT THE ASSAY AND THE MODULE WERE AGAIN PERFORMING ACCORDING TO SPECIFICATIONS. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO A COMPONENT MALFUNCTION. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE FERR4 (TINA-QUANT FERRITIN GEN.4) RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS 8000 C702 MODULE. THE REPORTER WAS ABLE TO PROVIDE ONE PATIENT SAMPLE WITH DISCREPANT RESULTS: THE INITIAL RESULT FROM THE C 702 MODULE WAS 0 NG/ML. THE INITIAL RESULT IN THE COBAS INFINITY WAS <5 U/L. THE REPEAT RESULT FROM THE C 702 MODULE WAS 45 NG/ML. THE REPEAT RESULT IN THE COBAS INFINITY WAS 45 U/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121681 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male