BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3142478 · Received June 3, 2013

    Report

    Report Number
    1823260-2013-03307
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDD
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. RESULTS - DEVICE SUBASSEMBLY- FLUIDIC FITTING.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS ON VITAMIN B12 (B12) FOR ONE PATIENT. ALL RESULTS ARE IN PG/ML. THE SAMPLE WAS RUN ON (B)(6) 2013 "AROUND 1030". THE INITIAL RESULT WAS <30, WHICH WAS REPORTED OUTSIDE OF THE LABORATORY. LATER THAT EVENING, THE RESULT WAS QUESTIONED BY THE PATIENT, SO THE SAMPLE WAS REPEATED ON THE SAME ANALYZER. THE REPEAT RESULT WAS 751, AND WAS DEEMED TO BE THE CORRECT RESULT BY THE CUSTOMER. A CORRECTED REPORT WAS ISSUED. THERE WAS NO ADVERSE EVENT. THE SAMPLE WAS ALSO REPEATED ON ANOTHER COBAS 6000, E601 MODULE AND GENERATED A VALUE OF "AROUND 700". THE LOT OF B12 REAGENT IN USE WAS 17094306, WITH AN EXPIRATION DATE OF 12/31/2013. THE FIELD SERVICE REPRESENTATIVE FOUND THE FLUIDIC FITTING TO THE SAMPLE PROBE WAS LOOSE, AND THE SAMPLE PROBE WAS LOSING PRIME. HE TIGHTENED THE FLUIDIC FITTING TO THE SAMPLE PROBE AND PERFORMED A SYSTEM AIR PURGE AND PRIME. HE ALSO PERFORMED SERVICE CHECKS AND PRECISION CHECKS, WHICH ALL PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245042 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER CDD ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1