BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2195680 · Received August 8, 2011

    Report

    Report Number
    1823260-2011-04278
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 10, 2011
    Report Date
    September 14, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LJK
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEW INFORMATION WAS ADDED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. ONE SAMPLE WAS PROVIDED FOR INVESTIGATION AND THE POSITIVE TOXOPLASMA IGG RESULT OBTAINED BY THE CUSTOMER COULD NOT BE VERIFIED. THIS SAMPLE TESTED NEGATIVE FOR TOXOPLASMA IGG AS WELL AS TOXOPLASMA IGM AND WAS CONSISTENT WITH THE RESULTS OBTAINED FROM THE COMPETITOR ASSAY. THE CUSTOMER CONFIRMED THE INVESTIGATION RESULTS AND NO FURTHER INVESTIGATION WAS DONE. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE. THE DISCREPANT RESULTS LED TO AN UNCLEAR TOXOPLASMA IGG STATUS FOR THE PATIENT. THE TOXOPLASMA IGG REAGENT (IGG ANTIBODIES TO TOXOPLASMA GONDII) LOT NUMBER WAS 161442. THE ROCHE ELECSYS RESULT WAS 301.50 IU/ML. THE CONFIRMATORY TEST RESULT (USING A LIASON INSTRUMENT) WAS <3.0 IU/ML. IT IS UNKNOWN WHICH RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NO ADVERSE EVNETS HAVE BEEN ALLEGED REGARDING THE DISCREPANCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER LJK ROCHE DIAGNOSTICS NA 2119-04

    Patients

    Seq Age Sex Outcome Treatment
    1