BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 17617610 · Received August 24, 2023

    Report

    Report Number
    1823260-2023-02765
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    June 26, 2023
    Report Date
    August 24, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630930845
    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 CREJ AND PHO REAGENTS' LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE DEGASSER, THE CUVETTES, THE HEAT CUT FILTER AND THE LAMP. HE ALSO WASHED THE CUVETTES, DID MEASUREMENT OF THE BLANK CELL AND ADJUSTED THE GEAR PUMP. CALIBRATION AND QC WERE PERFORMED AND THEY WERE ACCEPTABLE. PERFORMANCE CHECK WAS DONE AND THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE EVENT WAS CONSISTENT WITH A MAINTENANCE ISSUE. THE SERVICE ACTIONS (MAINTENANCE ACTIVITIES) RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH CREATININE (CREJ) ASSAY AND 1 PATIENT'S SAMPLE TESTED WITH PHOSPHOROUS (PHO) ASSAY ON A COBAS 8000 C702 ANALYZER. SAMPLE 1: INITIAL CREJ RESULT: 1.24 MG/DL REPEAT CREJ RESULT: 3.98 MG/DL. SAMPLE 2: INITIAL CREJ RESULT: 1.44 MG/DL REPEAT CREJ RESULT: 4.03 MG/DL. SAMPLE 3: INITIAL PHO RESULT: 0.8 MG/DL REPEAT PHO RESULT: 2.0 MG/DL. IT IS UNKNOWN AT THIS POINT IF THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167366 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630930845

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown