BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1931053 · Received December 17, 2010

    Report

    Report Number
    1823260-2010-07535
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 5, 2010
    Report Date
    January 4, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GMN
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE PATIENT SAMPLE VERIFIED THE POSITIVE ELECSYS TOXOPLASMA IGG RESULTS. THE POSITIVE RESULTS WAS FURTHER CONFIRMED BY NEUTRALIZATION ASSAY AS WELL AS COMPETITOR ASSAYS, BOUTY BEIA TOXOPLASMA IGG ASSAYS (QUANT AND AVIDITY). THE ELCSYS TOXOPLASMA IGG RESULTS ARE REGARDED AS CORRECTLY REACTIVE. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE TOXOPLASMA IGG (IGG ANTIBODIES TO TOXOPLASMA GONDII) FOR ONE PATIENT SAMPLE. THE INITIAL TOXOPLASMA IGG RESULT WAS 121.4 IU/ML. THE PHYSICIAN ORDERED ADDITIONAL TESTING BE PERFORMED. THE SAMPLE WAS REPEATED USING AN UNKNOWN COMPETITOR ASSAY, IT GENERATED A NEGATIVE RESULT. AVIDITY TESTING PERFORMED ON THE SAMPLE WAS ALSO NEGATIVE. THE PATIENT'S TOXOPLASMA IGM RESULTS HAVE ALWAYS BEEN NEGATIVE. ALL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND TO THE PHYSICIAN. THE PATIENT WAS NOT HARMED BY THE EVENT. THE TOXOPLASMA IGG REAGENT LOT NUMBER WAS 00158276.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 032 YR