BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1904931 · Received November 22, 2010

    Report

    Report Number
    1823260-2010-06865
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 6, 2010
    Report Date
    January 7, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEW INFORMATION WAS RECEIVED INDICATING THE DATE OF EVENT WAS (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE EVENT DETERMINED THE ROOT CAUSE WAS A PRE- ANALYTICAL ISSUE. AN ONSITE INVESTIGATION OF THE ISSUE FOUND GEL AT THE SURFACE OF THE SAMPLE PROBE AND OIL ON TOP OF THE SECONDARY TUBES. THE INCORRECT RESULTS WERE CAUSED BY THE PIPETTING OF OIL FROM THE TOP OF THE SERUM TUBE SURFACE OR THE MIS-SAMPLING OF SERUM WHICH WAS PARTLY REPLACED BY GEL. THE TUBE MANUFACTURER, BECTON DICKINSON, WAS INVOLVED IN THE ROOT CAUSE INVESTIGATION. THE FOLLOWING RECOMMENDATIONS WERE GIVEN TO THE CUSTOMER: THE PRE- ANALYTICAL WORKFLOW SHOULD BE REVIEWED INTENSIVELY BY THE TUBE MANUFACTURER AND THE ANALYZER CHECKED COMPLETELY. ALSO A DAILY VISUAL CHECK AND CLEANING OF THE SAMPLE PROBE WITH WATER OR ALCOHOL AND A LINT FREE TISSUE SHOULD BE DONE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN THE (B)(6).

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE GLUCOSE HK GENERATION 3(GLUCOSE) RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.2 MMOL/L AND THE REPEAT RESULT WAS 22.0 MMOL/L. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE EVENT. THE GLUCOSE REAGENT LOT NUMBER WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND THE SAMPLE PROBE WAS DIRTY INSIDE AND OUT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1