BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1833992 · Received September 14, 2010

    Report

    Report Number
    1823260-2010-05426
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    July 19, 2010
    Report Date
    December 9, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFX
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TWO SAMPLES WERE TESTED AS PART OF THE INVESTIGATION AND THE POSITIVE RUBELLA IGG RESULTS WERE CONFIRMED. THE PRESENCE OF ANTI-RUBELLA IGG WAS ALSO CONFIRMED, THEREFORE THE SAMPLES CLEARLY CONTAINED SPECIFIC IGG. THE ELECSYS RUBELLA IGG RESULTS WERE REGARDED CORRECT AS POSITIVE. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RUBELLA IGG RESULTS FOR TWO SAMPLES FROM THE SAME PATIENT. SAMPLE 1 INITIAL RESULT WAS 54.54 UI/ML AND WAS REPORTED TO THE CLINICIAN WHO SENT THE PATIENT TO THE LABORATORY FOR A SECOND TEST TO CONFIRM THE RESULT. ON (B)(6) 2010, SAMPLE 2 INITIAL RESULT WAS 55.28 UI/ML. WHEN THE SECOND RESULT WAS REPORTED TO THE PHYSICIAN, HE CALLED THE LABORATORY AS THE PATIENT HAD PREVIOUSLY BEEN TESTED FOR RUBELLA IGG BY ANOTHER LABORATORY IN (B)(6) 2010. IN BOTH CASES, THE RESULTS HAD BEEN REPORTED TO BE BELOW 8 UI/ML. NO INFORMATION WAS PROVIDED ABOUT THE METHOD OF TESTING USED FOR THESE SAMPLES. THE USER SENT SAMPLES 1 AND 2 TO ANOTHER LABORATORY TO CONFIRM THE INITIAL RESULTS. BOTH SAMPLES WERE TESTED WITH THE EIA BIOMERIEUX TECHNIQUE AND GAVE RESULTS BELOW 10 UI/ML. THE PATIENT WAS NOT HARMED DUE TO THE DISCREPANCIES BETWEEN THE RESULTS. THE RUBELLA IGG REAGENT LOT NUMBER AT THE TIME SAMPLE 1 WAS INITIALLY TESTED WAS 156582. THE RUBELLA IGG REAGENT LOT NUMBER AT THE TIME SAMPLE 2 WAS INITIALLY TESTED WAS 157692.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1