BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2961356 · Received February 14, 2013

    Report

    Report Number
    1823260-2013-00871
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    December 11, 2012
    Report Date
    March 13, 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

    THE CUSTOMER HAS DECLINED TO PROVIDE FURTHER INFORMATION. A ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SUPPLIED ADDITIONAL INFORMATION. ALL THE UNITS OF MEASURE FOR ALL THE RESULTS WERE (B)(6). THE PATIENT'S INITIAL RESULT WAS (B)(6), WHICH WAS (B)(6).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE IGG ANTIBODIES TO RUBELLA VIRUS (RUB) RESULT ON THEIR E601 ANALYZER FOR ONE PATIENT. ALL THE OTHER SAMPLES TESTED ON THE DAY OF THE EVENT FOR RUB WERE REPEATED AND THERE WERE NO OTHER DISCREPANCIES. THE UNITS OF MEASURE WERE NOT PROVIDED. THE CUSTOMER STATED THE PATIENT'S INITIAL RUB RESULT WAS "0388" AND IT WAS REPORT OUTSIDE THE LABORATORY. IT IS UNCLEAR IF THE CUSTOMER MEANT 0.388, CLARIFICATION HAS BEEN REQUESTED. ON (B)(6) 2013, THE PATIENT'S SAMPLE WAS RE-TESTED AT A SERUM BANK AND THE RESULT WAS 227.3. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE RUB LOT NUMBER WAS 169621 AND THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65472 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER LFX ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 030 YR