BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 6112512 · Received November 18, 2016

    Report

    Report Number
    1823260-2016-01805
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    November 6, 2016
    Report Date
    November 18, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UDI: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT SAMPLE TESTED FOR VANC2 VANCOMYCIN (VANC2). THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL VANC2 RESULT WAS LESS THAN 1.7 (UNIT OF MEASURE NOT PROVIDED). THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 26.4 AND 25.6. NO ADVERSE EVENT OCCURRED. THE VANC2 REAGENT LOT NUMBER WAS 140735. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. CALIBRATION AND QUALITY CONTROLS WERE ACCEPTABLE. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED. A GENERAL REAGENT OR INSTRUMENT ISSUE CAN BE EXCLUDED SINCE THE PRECISION TEST RESULTS FROM THE CUSTOMER WERE WITHIN SPECIFICATION. THE CAUSE OF THE ISSUE IS BELIEVED TO BE A CLOGGED SAMPLE PROBE. THE CUSTOMER CLEANED THE SAMPLE PROBE MANUALLY AND, AFTER MAINTENANCE, THE ISSUE WAS RESOLVED. BASED ON THE INFORMATION AVAILABLE FOR INVESTIGATION, THE MOST PROBABLE ROOT CAUSE IS RELATED TO PRE-ANALYTICAL ISSUES LEADING TO INSUFFICIENT SAMPLE PIPETTING. INSUFFICIENT SAMPLE PIPETTING COULD BE CAUSED BY FOAM ON TOP OF THE SAMPLE PIPETTING OR FIBRIN FORMATIONS IN THE SAMPLE. ASPIRATION OF FIBRIN CAN LEAD TO PHYSICAL OBSTRUCTION OF THE PROBE. FIBRIN CLOTS CAN OCCUR DUE TO INCOMPLETE COAGULATION OF THE SAMPLE DUE TO SHORT CLOTTING OR CENTRIFUGATION TIME OR BY USING A G-FORCE THAT IS TOO LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765982 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR