BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 3190428 · Received June 26, 2013

    Report

    Report Number
    1823260-2013-03859
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 10, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGA
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A ROOT CAUSE DUE TO LACK OF INFORMATION PROVIDED BY THE CUSTOMER. INFORMATION WAS REQUESTED BUT NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR GLUCOSE HK (GLU) ON ONE PATIENT SAMPLE. ALL RESULTS ARE IN MG/DL. THE PATIENT'S INITIAL RESULT WAS 120, ACCOMPANIED BY A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN ADDED ANOTHER TEST TO THE ORDER AND THE SAME SAMPLE WAS REPEATED. THE REPEAT GLU RESULT WAS 174, ACCOMPANIED BY A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE RESULT WAS QUESTION BY THE PATIENT, WHO IS A NURSE. THE SAMPLE WAS REPEATED A THIRD TIME FOR TROUBLESHOOTING PURPOSES AND GENERATED A RESULT OF 117, ACCOMPANIED BY A DATA FLAG. THE ORIGINAL RESULT OF 120, ACCOMPANIED BY A DATA FLAG WAS DEEMED TO BE CORRECT RESULT BY THE CUSTOMER. THERE WAS NO ADVERSE EVENT. THE LOT OF GLU REAGENT IN USE WAS 67526101, WITH AN EXPIRATION DATE OF 04/30/2014. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE FOR THE ISSUE. HE CHECKED THE FUNCTIONALITY OF THE INSTRUMENT. HE DID A PRECISION RUN, WHICH MET SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290855 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER CGA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 039 YR