BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 6934546 · Received October 10, 2017

    Report

    Report Number
    1823260-2017-02236
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    September 20, 2017
    Report Date
    November 27, 2017
    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

    THE FIELD SERVICE REPRESENTATIVE FOUND THE CELL RINSE WATER VOLUME WAS OUT OF ADJUSTMENT. HE ADJUSTED CELL RINSE WATER VOLUME AND RAN ALL PERFORMANCE CHECKS WHICH PASSED. TRENDING WAS PERFORMED ON THIS TYPE OF COMPLAINT AND NO OTHER ABNORMAL TREND WAS IDENTIFIED. A QUERY WAS PERFORMED AND FOUND NO PAST ISSUES OF THIS NATURE ON ANY LIKE INSTRUMENTS FOR THE LAST 12 MONTHS AT THIS SITE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE ANALYZER WAS LEAKING ONTO THE FLOOR AND THE WATER BATH WAS OVERFLOWING. THEY CLEANED UP THE WATER AND NOTICED THE RINSE MECHANISM WAS NOT TIGHTENED DOWN PROPERLY. THE CUSTOMER REPLACED THE REACTION CELLS AND TIGHTENED DOWN THE RINSE MECHANISM. THE CUSTOMER DECIDED TO REPEAT SOME PATIENT SAMPLES AND FOUND DISCREPANT A1C-2 TINA-QUANT HEMOGLOBIN A1C GEN. 3 RESULTS FOR THREE PATIENT SAMPLES. PATIENT 1 INITIAL RESULT WAS 4.2 % AND WAS REPORTED OUTSIDE THE LABORATORY. THE DOCTOR CALLED AND QUESTIONED THE RESULT. THE REPEAT RESULT WAS 5.1 %. PATIENT 2 INITIAL RESULT WAS 4.4 % AND WAS REPORTED OUTSIDE THE LABORATORY. THE DOCTOR CALLED AND QUESTIONED THE RESULT. THE REPEAT RESULT WAS 5.9 %. PATIENT 3 INITIAL RESULT WAS 4.4 % AND WAS REPORTED OUTSIDE THE LABORATORY. THE DOCTOR CALLED AND QUESTIONED THE RESULT. THE REPEAT RESULT WAS 6.0 %. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 242789. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE ADJUSTED THE RINSE WATER DISCHARGE VOLUME, REPAIRED A BROKEN VACUUM TUBE FOR THE DETERGENT RINSE NOZZLE, AND REPLACED A NOZZLE TIP. HE RAN A PRECISION CHECK FOR HBA1C AND ALL PERFORMANCE CHECKS PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715622 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1