BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1933830 · Received December 21, 2010

    Report

    Report Number
    1823260-2010-07567
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 30, 2010
    Report Date
    April 5, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. BASED UPON THE INFORMATION PROVIDED, THE FALSE LOW RESULT WAS OBTAINED WHEN USING A 13 MM PRIMARY SAMPLE TUBE WITHOUT USING THE RECOMMENDED RACK ADAPTERS. RACK ADAPTERS ARE STRONGLY RECOMMENDED TO ENSURE CORRECT PIPETTING. INCORRECT PIPETTING CAN LEAD TO INSUFFICIENT SAMPLE VOLUME FOR TESTING. THE MOST LIKELY CAUSE OF THIS EVENT IS PIPETTING OF INSUFFICIENT SAMPLE VOLUME. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE THYROTROPIN (TSH) RESULTS FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.062 UIU/ML. THIS RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE SAME SAMPLE WAS REPEATED AND GENERATED 2.42 UIU/ML. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY AND THE CUSTOMER CONSIDERED THIS RESULT TO BE CORRECT. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THERE WERE NO ADVERSE EVENTS REPORTED. THE TSH REAGENT LOT NUMBER WAS 159668.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JLW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 040 YR