BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 4000 C (311) STAND ALONE SYSTEM

    MDR report key: 7198964 · Received January 17, 2018

    Report

    Report Number
    1823260-2018-00149
    Event Type
    Malfunction
    Date Received
    January 17, 2018
    Date of Event
    January 3, 2018
    Report Date
    January 24, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPONENT CODE - DEVICE SUBASSEMBLY = CIRCULATION PATH.

    Additional Manufacturer Narrative · 1

    INVESTIGATIONS HAVE DETERMINED THAT THE ROOT CAUSE OF THE ISSUE WAS A FAILURE OF EITHER THE FLUIDICS OR CELL RINSE FUNCTIONALITY AS DESCRIBED BY THE FIELD SERVICE ENGINEER. NO SIMILAR EVENTS HAVE OCCURRED AT THE CUSTOMER SITE WITHIN THE PAST 12 MONTHS. THERE WERE NO ABNORMAL COMPLAINT TRENDS FOR THE PARTS REPLACED BY THE FIELD SERVICE ENGINEER.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR GLUC3 GLUCOSE HK GEN.3 (GLU) ON A COBAS 4000 C (311) STAND ALONE SYSTEM - C311. THE SAMPLE INITIALLY RESULTED AS 183.6 MG/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON A COBAS C 111 ANALYZER, RESULTING AS 113.33 MG/DL. THE SAMPLE WAS ALSO REPEATED ON THE C311, RESULTING AS 117.8 MG/DL. BOTH REPEAT VALUES WERE BELIEVED TO BE CORRECT AND THE 117.8 MG/DL VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE GLU REAGENT LOT NUMBER WAS 203181. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER DETERMINED THAT THERE WAS A FAILURE OF EITHER THE FLUIDICS OR CELL RINSE FUNCTIONALITY. HE ALSO NOTED THAT THERE WAS WEAR AND TEAR ON THE HEAT CUT FILTER. HE CHECKED TO ENSURE THAT THE CUSTOMER PERFORMED PROPER AND TIMELY MAINTENANCE ON THE ANALYZER, ESPECIALLY THE MONTHLY EXCHANGE OF REACTION CELLS. HE CHECKED FOR CORRECT RINSE LEVELS AND MOVEMENT OF RINSE NOZZLES. HE ADJUSTED THE WASH MECHANISM. HE CLEANED THE CIRCULATION PATH. HE REPLACED THE HEAT CUT FILTER AND NOZZLE TIPS. HE RE-ASSEMBLED ALL COMPONENTS AND PERFORMED OPERATION CHECKS. THERE WERE NO ABNORMALITIES FOUND WHEN PERFORMING MECHANISM CHECKS. HE PERFORMED CELL BLANK MEASUREMENTS AND PHOTOMETER CHECKS. THE ULTRASONIC MIXER SHOWED A PERFORMANCE ISSUE. HE RAN CONTROL MATERIAL AND RESULTS WERE WITHIN RANGE. THE CUSTOMER RAN CONTROLS AND THESE PASSED WITHIN THE LABORATORY'S SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44596 COBAS 4000 C (311) STAND ALONE SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C311 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR