BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C (701) MODULE

    MDR report key: 6408896 · Received March 16, 2017

    Report

    Report Number
    1823260-2017-00568
    Event Type
    Malfunction
    Date Received
    March 16, 2017
    Date of Event
    February 28, 2017
    Report Date
    March 16, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER HAD AN ONGOING ISSUE WITH CRPL3 C-REACTIVE PROTEIN GEN.3 AND RECEIVED QUESTIONABLE RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES. THE CUSTOMER REPEATED THE TESTING ON ANOTHER ANALYZER. OF THE DATA PROVIDED, ONLY THE RESULTS FOR FOUR PATIENT SAMPLES WERE DISCREPANT. (B)(6). ADDITIONAL RESULTS WERE PROVIDED FOR EACH PATIENT (MG/L). CLARIFICATION WAS REQUESTED FOR THESE RESULTS, BUT COULD NOT BE PROVIDED. (B)(6). INFORMATION REGARDING IF ANY ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT IT WAS UNKNOWN. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 202453. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. REVIEW OF THE PROVIDED CALIBRATION AND PRECISION DATA FOUND THEY WERE ACCEPTABLE AND DID NOT INDICATE ANY ISSUES. AN ISSUE WITH SAMPLE QUALITY COULD BE EXCLUDED AS NO ABNORMAL SAMPLE ASPIRATION ALARMS WERE PRESENT. THE FIELD SERVICE REPRESENTATIVE CLEANED THE WASH TUBING WHICH WAS BLOCKED AND REMOVED AND CLEANED ALL ULTRASONIC MIXERS. THE SYSTEM WAS TESTED AND WAS OKAY. QC WAS PERFORMED AND WAS OKAY. AS NO FURTHER EVENTS WERE REPORTED AFTER THE SERVICE VISIT, CONTAMINATION OF THE FLOW PATH WAS THE ROOT CAUSE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193981 COBAS 8000 C (701) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1