BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3251686 · Received July 29, 2013

    Report

    Report Number
    1823260-2013-04508
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    October 8, 2012
    Report Date
    November 4, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFX
    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

    A SAMPLE FROM THE PATIENT WAS SUBMITTED FOR FURTHER INVESTIGATION AND THE CUSTOMER'S RESULT WAS CONFIRMED. IN FURTHER TESTING, THE SAMPLE SHOWED EVIDENCE OF CONTAINING SPECIFIC IGG TO RUBELLA. THE SAMPLE CAN BE CONSIDERED REACTIVE AND THEREFORE THE POSITIVE ELECSYS RUBELLA IGG RESULT WAS LIKELY CORRECT.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE (B)(6) RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS (B)(6). THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND THE RESULT WAS (B)(6) WHICH WAS CONSIDERED TO BE (B)(6). THE RESULT WAS ALSO (B)(6). AN ADDITIONAL RESULT OF (B)(6) UI/ML FROM (B)(6) 2013 WAS PROVIDED AND BELIEVED TO BE A SECOND ANALYSIS OF THIS SAMPLE. CLARIFICATION HAS BEEN REQUESTED. NO INFORMATION WAS PROVIDED TO DETERMINE WHICH RESULT WAS REPORTED OUTSIDE THE LABORATORY OR IF THE PATIENT WAS ADVERSELY AFFECTED. THE (B)(4) REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351951 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER LFX ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 019 YR