BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3922175 · Received July 9, 2014

    Report

    Report Number
    1823260-2014-05019
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 9, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    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 RESULTS ON THEIR E601 ANALYZER. THE CUSTOMER STATED THEY WERE EXPERIENCING INSTRUMENT ALARMS ON ALL OF THEIR PATIENT SAMPLES. THE CUSTOMER NOTICED THE ISSUE BEGAN WHEN HE RAN A PATIENT SAMPLE WITH A THYROTROPIN (TSH) RESULT OF 0.0425 UIU/ML. ALL THE OTHER RESULTS ON THE PATIENT SAMPLE PRODUCED ALARMS. THE INITIAL THS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED ON A MODULAR E-MODULE AND THE RESULT WAS 2.67 MIU/ML. THE REPEAT RESULT WAS CONSIDERED CORRECT AND IT WAS SENT TO THE LABORATORY AS A CORRECTED REPORT. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. NO OTHER PATIENT RESULTS WERE PROVIDED BY THE CUSTOMER. THE TSH REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE CUSTOMER PERFORMED CORRECTIVE MAINTENANCE ON THE ANALYZER. THE CUSTOMER TRIED CLEANING THE SAMPLE PROBE. THE CUSTOMER STATED THE TUBE WAS NOT CLOGGED. THE CUSTOMER DECLINED A SERVICE VISIT BECAUSE THE CUSTOMER STATED THEY WERE ABLE TO RESOLVE THE ISSUE WITH THE CORRECTIVE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401429 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 054 YR