BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 3222408 · Received July 12, 2013

    Report

    Report Number
    1823260-2013-04214
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 26, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. THE DATA PROVIDED BY THE CUSTOMER WAS EVALUATED. THE QC RUNS FOR THE TSH ASSAY ARE OK. FOR BOTH COMPETITIVE ASSAYS AND SANDWICH ASSAYS, INCOMPLETE CLOTTING IN SERUM CAN LEAD TO FALSE NEGATIVE VALUES. IT WAS NOTED THAT THE COLLECTION TUBE WAS EXPIRED. ON FOLLOW UP, THE CUSTOMER INDICATED THAT THIS EVENT DID NOT RE-OCCUR.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR THYROTROPIN (TSH) AND FREE THYROXINE (FT4)ON ONE PATIENT SAMPLE. IT WAS DETERMINED THAT THE TSH RESULT WAS ERRONEOUS AND HAD BEEN REPORTED OUTSIDE OF THE LABORATORY. ALL RESULTS ARE IN UIU/ML. THE INITIAL TSH RESULT WAS 0.018. THE CUSTOMER CONSIDERED THIS RESULT TO BE LOW, BUT REPORTED IT OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED AND GENERATED A RESULT OF 0.884. THE CUSTOMER DEEMED THE REPEAT RESULT TO BE THE CORRECT RESULT. THERE WAS NO ADVERSE EVENT. THE CUSTOMER HAD CHECKED THE SAMPLE FOR DEBRIS BEFORE THE FIRST RUN AND NOTED WHAT WAS THOUGHT TO BE A CLOT OR FIBRIN IN THE BOTTOM OF THE TUBE. THE CUSTOMER PUT THE SAMPLE BACK IN THE CENTRIFUGE, BUT DID NOT PROVIDE THE LENGTH OF TIME. THE CUSTOMER ALSO NOTED THAT ANOTHER TECH NOTICED WHAT APPEARED TO BE SOME FIBRIN AFTER THE INITIAL RUN AND WAS ABLE TO REMOVE IT. THE LOT OF TSH REAGENT IN USE WAS 17122601, WITH AN EXPIRATION DATE OF 09/30/2013. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE FOR THE ISSUE. HE CHECKED THE OPERATION OF THE ANALYZER. PERFORMANCE TESTING PASSED WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321993 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER JLW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NEWLASTA| DEXAMETHAZONE| "D5W"| FLUOROURACIL| ALOXI| ELOXATIN| COMPAZINE| "EMLA"| "VIT D"