BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3222409 · Received July 12, 2013

    Report

    Report Number
    1823260-2013-04215
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 26, 2013
    Report Date
    July 11, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR CONNECTING PEPTIDE (C- PEP) ON APPROXIMATELY 60 SAMPLES. OF THOSE SAMPLES, IT WAS DETERMINED THAT ONE SAMPLE HAD ERRONEOUS RESULTS THAT WERE REPORTED OUTSIDE OF THE LABORATORY. ALL RESULTS ARE IN NG/ML. THE CUSTOMER HAD RECEIVED SEVERAL DIFFERENT ERROR MESSAGES FROM THE INSTRUMENT. THE NIGHT OF (B)(6) 2013, THE END OF RUN QC WAS OUT OF RANGE. THE CUSTOMER ALSO NOTICED SIGNIFICANT BUBBLES IN THE LINE FROM THE SIPPER PIPETTOR. THE CUSTOMER HAD CHANGED THE S/R PROBE, WHICH SEEMED TO HELP FOR A LITTLE. THE INITIAL RESULT WAS 1.5. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AFTER THE FIELD SERVICE REPRESENTATIVE COMPLETED MAINTENANCE ACTIVITIES TO CORRECT ISSUES WITH QC RECOVERY. THE REPEAT RESULT WAS 0.8. THE CUSTOMER DEEMED THE REPEAT RESULT TO BE THE CORRECT RESULT. IT IS UNKNOWN IF THERE WAS AN ADVERSE EVENT. THE CUSTOMER DID NOT HAVE ANY PATIENT INFORMATION. THE LOT OF C-PEP IN USE WAS 16984001, WITH AN EXPIRATION DATE OF 12/31/2013. THE FIELD SERVICE REPRESENTATIVE FOUND THE WATER SUPPLY TUBING TO THE SAMPLE SYRINGE ASSEMBLY WAS KINKED. HE RE-CONNECTED THE TUBING TO THE SAMPLE SYRINGE ASSEMBLY. THE SYSTEM WAS INITIALIZED AND A MECHANISM CHECK WAS PERFORMED WITHOUT ERRORS. THE CUSTOMER PERFORMED AND ACCEPTED CALIBRATION AND QC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324222 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1