BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2274644 · Received October 4, 2011

    Report

    Report Number
    1823260-2011-05212
    Event Type
    Malfunction
    Date Received
    October 4, 2011
    Date of Event
    September 6, 2011
    Report Date
    March 27, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LJK
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD NEGATIVE TOXO IGG RESULTS ON A VIDAS ANALYZER FOR THE PREVIOUS EIGHT MONTHS.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THE EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE WAS RETURNED FOR INVESTIGATION. REACTIVE/POSITIVE RESULTS WERE OBTAINED. THE POSITIVE TOTO IGG RESULT IS REGARDED AS CORRECTLY POSITIVE. THE PATIENT WAS NOT HARMED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE IGG ANTIBODIES TO TOXOPLASMA GONDII (TOXO IGG) RESULTS ON THEIR E601 ANALYZER. THE PATIENT WAS BEING MONITORED MONTHLY DURING HER PREGNANCY FOR TOXO IGG USING A VIDAS ANALYZER WITH NEGATIVE RESULTS, <8 IU/ML. PRIOR TO DELIVERY, THE PATIENT'S TOXO IGG RESULTS WERE 88 IU/ML AND 86 IU/ML ON THE E601 ANALYZER. THE PATIENT'S SAMPLE WAS SENT TO ANOTHER LABORATORY FOR REPEAT TESTING AS THE PATIENT HAD BEEN TESTING NEGATIVE FOR TOXO IGG. THE SAMPLE WAS REPORTED AS NEGATIVE USING A VIDAS ANALYZER. THE CUSTOMER CONSIDERS THE RESULTS FROM THE E601 TO BE FALSE POSITIVE RESULTS. THERE WERE NO ALLEGATIONS OF ADVERSE AFFECTS TO THE PATIENT AS A RESULT OF THIS EVENT. THE TOXO IGG REAGENT LOT NUMBER WAS 161442 AND THE EXPIRATION DATE WAS 12/30/2011. NO ROOT CAUSE HAS BEEN DETERMINED. THE INVESTIGATION IS ONGOING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 030 YR