BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 3810476 · Received May 14, 2014

    Report

    Report Number
    1823260-2014-03439
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE TESTOSTERONE, FREE THYROXINE (FT4), AND THYROTROPIN (TSH) RESULTS ON THEIR E411 ANALYZER. THE CUSTOMER STATED THEY HAD BEEN GETTING INSTRUMENT ALARMS. THEY REPORTED OUT THE DISCREPANT RESULTS AND THE PHYSICIAN QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED AND CORRECTED REPORTS ISSUED. THE FIRST PATIENT'S INITIAL TESTOSTERONE RESULT WAS 4 NG/DL ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS 1029 NG/DL. THE SECOND PATIENT'S INITIAL FT4 RESULT WAS <0.0 NG/DL ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS 1.3 NG/DL. THE THIRD PATIENT'S INITIAL FT4 RESULT WAS <0.0 NG/DL ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS 0.2 NG/DL. THE FOURTH PATIENT'S INITIAL TSH RESULT WAS <0.04 UIU/ML ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS 1.11 UIU/ML. THE FIFTH PATIENT'S INITIAL TSH RESULT WAS <0.04 UIU/ML ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS 2.42 UIU/ML. THERE WERE NO ADVERSE EVENTS. THE TESTOSTERONE REAGENT LOT NUMBER WAS 17454805 AND THE EXPIRATION DATE WAS 02/28/2015. THE FT4 REAGENT LOT NUMBER WAS 17483301 AND THE EXPIRATION DATE WAS 11/30/2014. THE TSH REAGENT LOT NUMBER WAS 17616001 AND THE EXPIRATION DATE WAS 09/30/2014. THE FIELD SERVICE REPRESENTATIVE FOUND AN ISSUE WITH THE SR PROBE ADJUSTMENT. HE FOUND THE ENTIRE DEVICE OVERHANGING THE REAR EDGE OF THE CART BY ABOUT SIX INCHES. HE MOVED THE INSTRUMENT BACK ONTO THE CART WITH THE FRONT EDGE FLUSH TO THE FRONT OF THE CART. HE ADJUSTED THE SR PROBE TO THE SAMPLE RACK. THE CUSTOMER VERIFIED THE QUALITY CONTROL PER THE LABORATORY'S PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288816 COBAS E411 RACK SYSTEM IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1