BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C (701) MODULE

    MDR report key: 6496817 · Received April 17, 2017

    Report

    Report Number
    1823260-2017-00792
    Event Type
    Malfunction
    Date Received
    April 17, 2017
    Date of Event
    March 31, 2017
    Report Date
    April 17, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE HIGH CREATININE RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES. INFORMATION WAS PROVIDED AS A FIRST RESULT OF "2" MG/DL AND A REPEAT RESULT OF "1" MG/DL. PRECISION TESTING WAS PERFORMED ON (B)(6) 2017 AND SEVERAL OUTLIERS WERE NOTED. SPECIFIC DATA WAS ONLY PROVIDED FOR ONE PATIENT SAMPLE THAT WAS TESTED ON (B)(6) 2017. THE INITIAL RESULT WAS 2.70 MG/DL AND THE REPEAT RESULT WAS 0.79 MG/DL. ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY, BUT CORRECTED VALUES WERE IMMEDIATELY SENT TO THE MEDICAL PERSONNEL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 233171. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE CUSTOMER MOVED THE REAGENT ONTO THE OTHER DISK OF THE ANALYZER AND HAD NO ISSUES. THE SAMPLE PROBE AND REAGENT PROBE FOR THE ORIGINAL DISK WERE REPLACED AND PRECISION TESTING WAS PERFORMED WHICH WAS ACCEPTABLE. THE CUSTOMER HAD NO ISSUES FOR TWO DAYS, BUT THEN THE ISSUE RECURRED. THE FIELD SERVICE REPRESENTATIVE CHECKED THE ANALYZER AND DETERMINED ONE TUBE OF THE RINSE STATION WAS LEAKING AND WAS REPLACED. AFTERWARDS ALL CALIBRATION AND QC WAS WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278650 COBAS 8000 C (701) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1