BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 2367385 · Received December 12, 2011

    Report

    Report Number
    1823260-2011-06648
    Event Type
    Malfunction
    Date Received
    December 12, 2011
    Date of Event
    November 17, 2011
    Report Date
    April 11, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LGD
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(4).

    Additional Manufacturer Narrative · 1

    ONE SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. THE CUSTOMER'S RESULTS WERE CONFIRMED WITH 3 DIFFERENT LOTS OF REAGENTS AND ALSO USING A VALIDATED NEUTRALIZATION ASSAY. IN ADDITION, A COMPETITOR ASSAY (B)(4) ALSO GAVE A POSITIVE RESULT. THE RESULTS OBTAINED BY THE CUSTOMER WERE CONSIDERED TO BE CORRECT. THERE WAS NO MALFUNCTION. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE "FALSE POSITIVE" TOXOPLASMA IGG RESULTS FOR TWO SAMPLES FROM ONE PATIENT. OF THE DATA PROVIDED, THE RESULT FOR ONE SAMPLE WAS DISCREPANT. THE INITIAL RESULT WAS 41.43 IU/ML AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS TESTED ON AN ABBOTT ARCHITECT ANALYZER AND THE RESULT WAS "NEGATIVE". ON (B)(6) 2011, THE SAMPLE WAS RETESTED ON THE ORIGINAL ANALYZER AND THE RESULT WAS 40.94 IU/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TOXOPLASMA IGG REAGENT LOT NUMBER WAS 163699.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER LGD ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 030 YR INSULINE