BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 10355174 · Received August 3, 2020

    Report

    Report Number
    1823260-2020-01863
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    July 9, 2020
    Report Date
    December 21, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE SITE AND FOUND THAT A LEAKING RINSE TUBE AT THE RINSE STATION. THE ENGINEER HAS REPLACED THE TUBES AND CONFIRMED THE INSTRUMENT IS RUNNING WITHIN SPECIFICATIONS. THE INVESTIGATION DETERMINED THAT THE ISSUE FOUND BY THE FIELD SERVICE ENGINEER WAS THE ROOT CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE CUSTOMER REPLACED THE NA ELECTRODE TWICE, CHANGED THE ISE REAGENTS, VERIFIED NO SALT DEPOSITS WERE WITHIN THE ISE COMPARTMENT, AND PRIMED THE ISE SYSTEM SEVERAL TIMES. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT GEN.2 NA RESULTS FOR THREE PATIENTS TESTED ON A COBAS 6000 C (501) MODULE. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE SAMPLES WERE REPEATED FOR CONFIRMATION. PATIENT 1'S INITIAL NA RESULT WAS 151 MMOL/L, AND A REPEAT RESULT OF 141 MMOL/L. PATIENT 2'S INITIAL NA RESULT WAS 163 MMOL/L, AND A REPEAT RESULT OF 140 MMOL/L. PATIENT 3'S INITIAL NA RESULT WAS GREATER THAN 180 MMOL/L, AND A REPEAT RESULT WAS 139 MMOL/L. NA ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818898 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1