BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 4752910 · Received May 6, 2015

    Report

    Report Number
    1823260-2015-03424
    Event Type
    Malfunction
    Date Received
    May 6, 2015
    Date of Event
    April 16, 2015
    Report Date
    May 21, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. ADDITIONAL INFORMATION REQUIRED FOR THE INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR ESTRADIOL (E2). THE SAMPLE INITIALLY RESULTED AS 1012 PG/ML. THE SAMPLE WAS REPEATED ON (B)(6) 2015 AND RESULTED AS 607.4 PG/ML. THE 607.4 PG/ML VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED TWICE ON (B)(6) 2015, RESULTING AS 39.71 PG/ML. AND 36.95 PG/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE ESTRADIOL REAGENT LOT NUMBER WAS 181908. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299057 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1