BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3222390 · Received July 12, 2013

    Report

    Report Number
    1823260-2013-04218
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    April 27, 2013
    Report Date
    July 17, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS UNABLE TO DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE WHEN TESTED FOR INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCG+SS). THE PATIENT WAS TESTED FOR HCG+SS AND A RESULT OF < 0.1 MUI/ML WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2013 THE GYNECOLOGIST PERFORMED AN ULTRASONIC EXAM AND DETERMINED THE PATIENT WAS PREGNANT. THE GYNECOLOGIST ESTIMATED THE PREGNANCY HAD BEGUN AROUND THE BEGINNING OF (B)(6). A SAMPLE THAT HAD BEEN DRAWN IN PARALLEL WITH THE ORIGINALLY TESTED SAMPLE WAS THAWED AND TESTED WITH AN HCG+SS RESULT OF 185, 246 MUI/ML. THE CUSTOMER STATED THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR TO AN INJURY OR ILLNESS OR DETERIORATION IN HEALTH. THE CUSTOMER STATED IT WAS UNKNOWN IF THEY PATIENT WAS HARMED BY ANY ACTIONS TAKEN DUE TO THE RESULT. THE LOT NUMBER OF HCG+SS REAGENT USED WAS 171601. THE CUSTOMER WAS ASKED FOR THE EXPIRATION DATE, BUT DID NOT PROVIDE IT. THE INVESTIGATION DETERMINED NO REAGENT ISSUE WAS EVIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321852 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 032 YR