BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 2031947 · Received March 28, 2011

    Report

    Report Number
    1823260-2011-01652
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 26, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LEH
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE IDENTIFIED. THE ALLEGATION OF CARRYOVER COULD NOT BE VERIFIED AS NEITHER RAW DATA OR REACTION KINETICS COULD BE PROVIDED.

    Description of Event or Problem · 1

    THE FIELD APPLICATION SPECIALIST REPORTED THE CUSTOMER RECEIVED A QUESTIONABLE VANCOMYCIN RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 33 UG/ML AND WAS GENERATED IMMEDIATELY AFTER A SAMPLE FROM ANOTHER PATIENT WHICH HAD A VANCOMYCIN RESULT 1286 UG/ML WITH A DATA FLAG. THE INITIAL RESULT WAS REPORTED TO THE FLOOR AND QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS RETESTED WITH A RESULT OF 20 UG/ML. THE CUSTOMER CONSIDERED THE REPEAT RESULT OF 20 UG/ML TO BE THE CORRECT VALUE AND A CORRECTED REPORT WAS ISSUED FOR THIS SAMPLE. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE VANCOMYCIN REAGENT LOT NUMBER WAS 15013600. THE USER DECLINED A SERVICE VISIT AND STATED THEY BELIEVED THAT THE PROBLEM WAS DUE TO CARRYOVER FROM THE VERY HIGH CONCENTRATION OF VANCOMYCIN IN THE FIRST SAMPLE AND WAS NOT RELATED TO AN ANALYZER PERFORMANCE ISSUE. THE USER INSTITUTED AND VALIDATED A SAMPLE PROBE WASH BETWEEN VANCOMYCIN SAMPLES TO PREVENT A RECURRENCE OF THE INCIDENT. THE USER STATED THAT THE LABORATORY WAS SATISFIED THE SYSTEM WAS PERFORMING AS EXPECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 029 YR VANCOMYCIN