BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 UL COBAS E+ CORE FIX CONFIG

    MDR report key: 1611626 · Received February 23, 2010

    Report

    Report Number
    1823260-2010-01171
    Event Type
    Malfunction
    Date Received
    February 23, 2010
    Date of Event
    December 17, 2009
    Report Date
    February 23, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFX
    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 IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PROBLEM WITH RUBELLA IGG EXTERNAL PROFICIENCY SAMPLE RESULTS. RUBELLA IGG REAGENT LOT WAS 154154. SHE PROVIDED PROFICIENCY SAMPLE RESULTS FOR FIVE SAMPLES, RESULTS FOR TWO OF THE SAMPLES WERE DISCREPANT, ALL REPEAT TESTING PERFORMED (B) (6) 2010. THE CUTOFF FOR A POSITIVE RUBELLA IGG RESULT IS > OR = THAN 10 IU/ML. 1ST PROFICIENCY SAMPLE, ORIGINAL REPORTED RESULT WAS 100.3 IU/ML, REPEATED TWICE GAVE 97.73 AND 0.857 IU/ML. THE EXTERNAL PROFICIENCY PASSING RESULT WAS POSITIVE. 2ND PROFICIENCY SAMPLE, ORIGINAL REPORTED RESULT WAS 0.332 IU/ML, REPEATED TWICE GAVE 190.3 AND 206.4 MIU/ML. THE EXTERNAL PROFICIENCY PASSING RESULT WAS POSITIVE. NO PATIENTS WERE INVOLVED, THERE HAVE NOT BEEN ANY ERRONEOUS PATIENT RESULTS. THE FIELD SERVICE REPRESENTATIVE AND FIELD APPLICATION SPECIALIST WERE UNABLE TO DETERMINE THE CAUSE OF THE DISCREPANCIES. THE FIELD APPLICATION SPECIALIST WAS UNABLE TO FIND DOCUMENTATION THAT SOME REQUIRED MAINTENANCE WERE PERFORMED BY THE CUSTOMER IN (B) (6) 2009 AND NOTED THIS AS A POSSIBLE CAUSE. INSTRUMENT AND PRECISION CHECKS WERE PERFORMED AND ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 UL COBAS E+ CORE FIX CONFIG CLINICAL CHEMISTRY ANALYZER LFX ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1