BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 17694207 · Received September 6, 2023

    Report

    Report Number
    1823260-2023-02905
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    August 9, 2023
    Report Date
    September 6, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630930845
    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 REAGENT LOT NUMBER AND THE EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE INVESTIGATION REVIEWED THE 09-AUG-2023 ALARM TRACE AND THE CUSTOMER¿S HANDLING OF PATIENT SAMPLES; NO ISSUES WERE NOTED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE MODULE AND CHECKED FOR CAUSES. THE FSE REPLACED THE GEAR-PUMP HEAD (GPH) AS IT WAS APPROACHING THE MAXIMUM NUMBER OF HOURS. HE ALSO REPLACED SAMPLE PROBES AS THEY WERE NOTED TO BE BENT. PRODUCT LABELING STATES "DAILY MAINTENANCE OF THE C 701 AND C 702 MODULES TO CLEAN THE OUTSIDE OF THE SAMPLE PROBES 1 OPEN THE REAR COVER OF THE MODULE. 2 REMOVE THE PLEXIGLASS COVER. 3 MOVE THE SAMPLE PROBES TO AN ACCESSIBLE POSITION. 4 WIPE THE OUTSIDE OF EACH SAMPLE PROBE WITH A LINT-FREE CLOTH MOISTENED WITH ALCOHOL: ¿ ALWAYS WIPE FROM TOP TO BOTTOM. ¿ HOLD THE PIPETTER ARM WITH ONE HAND AND WIPE WITH THE OTHER. DO NOT PLACE A LINT-FREE CLOTH MOISTENED WITH ALCOHOL ON THE INSTRUMENT SURFACE AS THE FINISH MAY BE DAMAGED. 5 REATTACH AND CLOSE ALL COVERS." THE INVESTIGATION DETERMINED THE EVENT WAS CAUSED BY INSUFFICIENT SERVICE MAINTENANCE AND OPERATOR MAINTENANCE. 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 A QUESTIONABLE ALBUMIN RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. THE INITIAL RESULT FROM LINE 2 WAS 118.1 WITH A DATA FLAG. THE FIRST REPEAT RESULT FROM LINE 2 WAS 27.1. THE SECOND REPEAT RESULT FROM LINE 3 WAS 34. THE THIRD REPEAT RESULT FROM LINE 3 WAS 34.6. THE UNIT OF MEASUREMENT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249354 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630930845

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown