BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C701 MODULE

    MDR report key: 4104918 · Received September 22, 2014

    Report

    Report Number
    1823260-2014-07207
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD A NUMBER OF HIGH PHOSPHATE (INORGANIC) VER.2 (PHOS) RESULTS THAT WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE AUTO-REPEATED BY THE ANALYZER AND IT WAS THESE AUTO-REPEAT RESULTS THAT WERE REPORTED OUTSIDE OF THE LABORATORY. THE ORIGINAL RESULT VALUES RECEIVED PRIOR TO THE AUTO-REPEAT VALUES WERE ASKED FOR, BUT NOT PROVIDED. THE SAMPLES HAD BEEN SAMPLED FOR THE TOTAL BILIRUBIN ASSAY PRIOR TO RUNNING THE PHOS TEST AND THE INSTRUMENT WASHES TO BE PERFORMED AFTER THE TOTAL BILIRUBIN TEST WERE NOT WORKING. THE SAMPLES WERE THEN REPEATED INDIVIDUALLY FOR ONLY THE PHOS TEST ON THE SAME ANALYZER OR A DIFFERENT ANALYZER MODULE AND THE RESULTS FROM THESE REPEATS WERE WITHIN NORMAL RANGE. A TOTAL OF "60 TO 70" SAMPLES WERE AFFECTED AND DATA WAS PROVIDED FOR A TOTAL OF 62 SAMPLES. ALL 62 SAMPLES HAD ERRONEOUS RESULTS THAT WERE REPORTED OUTSIDE OF THE LABORATORY. REFER TO THE ATTACHMENT FOR ALL SAMPLE RESULTS. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE PHOS REAGENT LOT NUMBER WAS 60020701. THE PHOS REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. IT WAS NOTED THAT THE NAOH WASH SOLUTION BOTTLE DID NOT DECREASE AS EXPECTED. THE ISSUE WAS BELIEVED TO HAVE OCCURRED AROUND 11 A.M.. AT 2 P.M. QUALITY CONTROLS WERE MEASURED FOR PHOS AND THESE WERE ALL HIGH. A NEW PHOS REAGENT CASSETTE WAS PUT ON THE ANALYZER WITH CALIBRATION SIGNALS NOT CHANGING AT ALL AND THE QUALITY CONTROLS STILL RECOVERING HIGH. THE FIELD SERVICE ENGINEER CHECKED THE BATH LEVEL AND THIS WAS OK. HE CHECKED THE ULTRASONIC MIXER'S HORIZONTAL POSITION. HE REMOVED AND CLEANED ALL OF THE ULTRASONIC MIXERS. HE CONFIRMED THAT ALL THE ULTRASONIC MIXER FREQUENCY SETTINGS WERE OK. HE FOUND THE GEAR PUMP PRESSURE TO BE 180 KPA. HE REPLACED THE GEAR PUMP HEAD AND ADJUSTED THE PRESSURE TO 320 KPA. HE ADJUSTED THE DETERGENT FILL LEVEL BY 1MM HIGHER IN THE CUVETTES. HE CHECKED THE WASH AND CELL BLANK LEVELS; THESE WERE OK. HE CONFIRMED THE PROBE ADJUSTMENTS AND EXTERIOR WASH LEVELS; THESE WERE OK. THE PHOTOMETER WAS CHECKED AND FOUND TO BE OK. HE CONFIRMED DETERGENT LEVELS AND ADJUSTED IN THE "SSW" ACCORDINGLY. THE CUSTOMER RAN CALIBRATIONS AND QUALITY CONTROLS; ALL, INCLUDING PHOS, WERE OK. THE CUSTOMER RAN PATIENTS WITHOUT ISSUE FOR 2 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587870 COBAS 8000 C701 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR