BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 3111667 · Received May 14, 2013

    Report

    Report Number
    1823260-2013-02928
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 21, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE WITH THE INFORMATION PROVIDED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS ON TROPONIN I SHORT TURN AROUND TIME (TNI STAT) FOR ONE PATIENT ON (B)(6) 2013 AND TWO PATIENTS ON (B)(6) 2013. OF THOSE THREE PATIENTS, TWO WERE FOUND TO HAVE ERRONEOUS RESULTS THAT WERE REPORTED OUTSIDE OF THE LABORATORY. ALL RESULTS ARE IN NG/ML. ON (B)(6) 2013, PATIENT 1 HAD AN INITIAL TNI STAT RESULT OF 1.46, ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND GENERATED A RESULT OF < 0.300, ACCOMPANIED BY A DATA FLAG. THE ORIGINAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DEEMED THE REPEAT RESULT TO BE CORRECT AND THERE WAS NO ADVERSE EVENT. ON (B)(6) 2013, PATIENT 2, FEMALE, (B)(6), HAD AN INITIAL TNI STAT RESULT OF 0.365, ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND GENERATED A RESULT OF < 0.300, ACCOMPANIED BY A DATA FLAG. THE ORIGINAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DEEMED THE REPEAT RESULT TO BE THE CORRECT RESULT AND THERE WAS NO ADVERSE EVENT. THE LOT OF TNI STAT REAGENT IN USE WAS 17026101, WITH AN EXPIRATION DATE OF 01/31/2014. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE FOR THE ISSUE. HE CHECKED THE ADJUSTMENTS AND PERFORMED MECHANICAL CHECKS, VOLTAGE CHECKS AND PERFORMANCE TESTING; WHICH ALL PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212961 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER MMI ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 087 YR