BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1666196 · Received April 23, 2010

    Report

    Report Number
    1823260-2010-02442
    Event Type
    Malfunction
    Date Received
    April 23, 2010
    Date of Event
    April 8, 2010
    Report Date
    August 13, 2010
    Product Code
    LOJ
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NO INTERFERENCE DUE TO HAMA WAS PRESENT AND THAT, AS THE RESULT ON THE ANALYTICAL E MODULE AGREED WITH THE RESULTS OBTAINED ON THE CENTAUR ANALYZER, A SAMPLE-SPECIFIC DIFFERENCE BETWEEN METHODS SEEMS TO BE PRESENT.

    Description of Event or Problem · 1

    THE USER RECEIVED DISCREPANT ALPHA1-FETOPROTEIN RESULTS FOR ONE PATIENT. THE CLINICIAN WAS EXPECTING A NEGATIVE RESULT POST SURGERY. MODULAR RESULT WAS 65.1 NG/ML (POSITIVE) REFERENCE LAB RESULT (DPC SYSTEM) WAS 4.0 NG/ML REFERENCE LAB RESULT (MODULAR E) WAS 83 NG/ML IMMULITE 2000 RESULT WAS 4.25 NG/ML. BECKMAN COULTER UNICEL RESULT WAS 65.66 NG/ML THE POSITIVE RESULT OF 65.1 NG/ML WAS REPORTED TO THE PATIENT. THE NEGATIVE RESULT FROM THE IMMULITE WAS REPORTED TOGETHER WITH THE FRACTION (L3= 1.1 NG/ML) PERFORMED BY THE REFERENCE LAB. THERE WAS NO INCORRECT TREATMENT OF THE PATIENT DUE TO THE RESULTS. THE ALPHA1-FETOPROTEIN REAGENT LOT NUMBER WAS 154156.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE THE SURGEON FIRED THE DEVICE ACROSS THE BOWEL ON THE MESENTERY AND THE RELOAD POPPED OUT OF THE DEVICE ,THE PATIENT STARTED TO BLEED AND THEY HAD TO CONVERT TO AN OPEN PROCEDURE TO REMOVE THE RELOAD. THE PATIENT DID NOT REQUIRE BLOOD PRODUCTS, HOW THEY CONTROLLED THE BLEEDING IS UNKNOWN. THEY HAD NO INFORMATION ON HOW THE PROCEDURE WAS COMPLETED. PATIENT IS STABLE, UNKNOWN IF ADDITIONAL TIME IN ICU WAS REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1