BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 2509889 · Received March 29, 2012

    Report

    Report Number
    1823260-2012-01661
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Date of Event
    February 21, 2012
    Report Date
    March 29, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDZ
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE TESTOSTERONE II RESULTS ON THEIR E411 ANALYZER. THE CUSTOMER PROVIDED DATA FOR TWO RESULTS, OF WHICH ONE WAS DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S INITIAL TESTOSTERONE RESULT WAS 1.68 NG/ML. ON THE NEXT DAY, THE REPEAT RESULT WAS 6.10 NG/ML. THERE WERE NO ADVERSE EVENTS. THE DATA PROVIDED BY THE CUSTOMER SHOWS THAT REAGENT LOT NUMBER (B)(4) WAS CALIBRATED IN (B)(6) 2011. ACCORDING TO THE QUALITY CONTROL RESULTS FROM (B)(6) 2012, THE CUSTOMER ALTERNATELY USED REAGENT LOT (B)(4) WHICH EXPIRES 05/31/2012, (B)(4) WHICH EXPIRED IN 12/31/2011, AND (B)(4) WHICH EXPIRED IN 09/30/2011. IT IS NOT CLEAR WHICH REAGENT LOT WAS IN USE WHEN THE CUSTOMER RECEIVED THE DISCREPANT RESULT. THE FIELD SERVICE REPRESENTATIVE FOUND THAT THE MIXER WAS IN THE WRONG ALIGNMENT AND MADE BUBBLES IN THE REAGENT BOTTLE. HE HAS CHECKED AND REALIGNED THE MIXER AND THE PROBLEM HAS NOT REOCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS E411 RACK SYSTEM IMMUNOCHEMISTRY ANALYZER CDZ ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1