BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3030196 · Received April 2, 2013

    Report

    Report Number
    1823260-2013-01965
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 12, 2013
    Report Date
    April 2, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDD
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS ON VITAMIN B12 (B12) FOR SIX PATIENT SAMPLES. OF THOSE SIX, IT WAS DETERMINED THAT ONE SAMPLE WAS ERRONEOUS. THE CUSTOMER STATED THAT ALL OF THE PATIENTS WERE ON B12 SUPPLEMENTS, SO THE PHYSICIANS EXPECTED THE VALUES TO BE IN THE NORMAL RANGE. ALL RESULTS ARE IN PG/ML. THE PATIENT HAD AN INITIAL B12 ON (B)(6) 2013 OF 67.76, ACCOMPANIED BY A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS REPEATED ON (B)(6) 2013 AND GENERATED RESULTS OF 44.03, ACCOMPANIED BY A DATA FLAG AND 635.7. THE CUSTOMER DEEMED THE REPEAT RESULTS TO BE THE CORRECT RESULTS. THERE WAS NO ADVERSE EVENT. THE LOT OF B12 REAGENT IN USE WAS 17094306, WITH AN EXPIRATION DATE OF 12/31/2013. THE FIELD SERVICE REPRESENTATIVE FOUND THAT THE WASH UNIT WAS OUT OF ADJUSTMENT. HE ADJUSTED THE SAMPLER LIQUID LEVEL DETECTION, AND ALSO PERFORMED PROBE ADJUSTMENTS. HE PERFORMED SYSTEM CHECKS, WHICH WERE WITHIN SPECIFICATION. THE CUSTOMER ALSO PERFORMED QC, WHICH WAS WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134160 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER CDD ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1