BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 4667674 · Received April 8, 2015

    Report

    Report Number
    1823260-2015-02840
    Event Type
    Malfunction
    Date Received
    April 8, 2015
    Date of Event
    March 20, 2015
    Report Date
    May 4, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. A GENERAL ISSUE WITH THE ANALYZER, REAGENT, OR CONTROL CAN BE EXCLUDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR TOTAL PROSTATE-SPECIFIC ANTIGEN (TPSA). THE SAMPLE INITIALLY RESULTED AS 0.009 NG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT BECAUSE THE LAST TPSA RESULT FOR THE PATIENT WAS "ABOUT 5 NG/ML". THE SAMPLE WAS REPEATED AND RESULTED AS 4.86 NG/ML. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE PATIENT WAS ADVERSELY AFFECTED. NO ADVERSE EVENTS WERE ALLEGED. THE TPSA REAGENT LOT NUMBER WAS 181690. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. IT WAS NOTED BY THE SALES REPRESENTATIVE THAT THE LABORATORY AT THE CUSTOMER SITE HAS HIGH HUMIDITY (OVER 50%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233201 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1