BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 ISE 900 MODULE

    MDR report key: 16361509 · Received February 13, 2023

    Report

    Report Number
    1823260-2023-00432
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    January 4, 2023
    Report Date
    February 21, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOR PATIENT 2 IT WAS CLARIFIED THAT THE RESULTS FROM (B)(6) 2023 (143 MMOL/L) AND (B)(6) 2023 (145 MMOL/L) WERE FROM THE SAME SAMPLE. THE RESULTS FROM (B)(6) 2023 (150 MMOL/L) AND (B)(6) 2023 (147 MMOL/L) WERE FROM A DIFFERENT SAMPLE.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) CLEANED THE VACUUM LINE AND SAMPLE LINE. THE FSE REPLACED A VALVE, A VACUUM NOZZLE, AND THE DILUTION BATH ASSEMBLY. THE INVESTIGATION DETERMINED THE ROOT CAUSE OF THE EVENT WAS CONSISTENT WITH A PRE-ANALYTICAL HANDLING ISSUE RESOLVED BY SERVICE MAINTENANCE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED THE RESULTS FOR "SEVERAL" PATIENTS TESTED FOR SODIUM (NA) ON A COBAS 8000 ISE MODULE. THE FOLLOWING ARE EXAMPLES OF QUESTIONABLE RESULTS FOR 2 PATIENT SAMPLES. FOR PATIENT 1: ON (B)(6) 2023, THE RESULT WAS 131 MMOL/L. ON (B)(6) 2023, THE RESULT WAS 133 MMOL/L. ON (B)(6) 2023, THE RESULT WAS 134 MMOL/L. ON (B)(6) 2023, THE RESULT WAS 139 MMOL/L. ON (B)(6) 2023, THE RESULT WAS 136 MMOL/L. FOR PATIENT 2: ON (B)(6) 2023, THE RESULT WAS 143 MMOL/L. ON (B)(6) 2023, THE RESULT WAS 145 MMOL/L. ON (B)(6) 2023, THE RESULT WAS 150 MMOL/L. ON (B)(6) 2023, THE RESULT WAS 147 MMOL/L. IT IS UNCLEAR WHETHER THESE RESULTS ARE FROM THE SAME SAMPLE OR SAMPLES OBTAINED ON DIFFERENT DAYS. CLARIFICATION WAS REQUESTED BUT HAS NOT BEEN PROVIDED. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE NA ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517209 COBAS 8000 ISE 900 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS COBAS 8000 ISE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown