BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2518027 · Received April 5, 2012

    Report

    Report Number
    1823260-2012-01800
    Event Type
    Malfunction
    Date Received
    April 5, 2012
    Date of Event
    February 20, 2012
    Report Date
    May 10, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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).

    Additional Manufacturer Narrative · 1

    ONE SAMPLE FROM THE PATIENT WAS TESTED AS PART OF THE INVESTIGATION. THE RESULTS FROM A COMPETITOR METHOD VERIFIED THE RESULTS OBTAINED BY THE CUSTOMER. THE SAMPLE WAS FURTHER TESTED AND AN INTERFERING FACTOR TO STREPTAVIDIN WAS IDENTIFIED AND WAS MOST LIKELY THE CAUSE. THIS INTERFERENCE IS DESCRIBED IN THE PRODUCT LABELING. THE PATIENT WAS NOT HARMED.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE FREE THYROXINE (FT4) AND THYROTROPIN (TSH) RESULTS FOR THREE SAMPLES FROM ONE PATIENT. OF THE DATA PROVIDED, TWO SAMPLES WERE RETESTED. ON (B)(6) 2012, THE INITIAL FT4 RESULT WAS 25.5 PMOL/L AND THE INITIAL TSH RESULT WAS 1.0 MIE/L. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND WAS TESTED ON A DELFIA SYSTEM ON (B)(6) 2012. THE FT4 RESULT WAS 15.9 PMOL/L AND THE TSH RESULT WAS 4.06 MIU/L. ON (B)(6) 2012, THE INITIAL FT4 RESULT WAS 26.0 PMOL/L AND THE INITIAL TSH RESULT WAS 0.54 MIE/L. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND WAS TESTED ON A DELFIA SYSTEM. THE FT4 RESULT WAS 15.2 PMOL/L AND THE TSH RESULT WAS 1.71 MIU/L. ALL RESULTS FROM THE COBAS E601 WERE REPORTED OUTSIDE THE LABORATORY. THE LABORATORY PHYSICIAN EVALUATED THE RESULTS AND THOUGHT THE FT4 RESULTS WERE TOO HIGH. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE FT4 REAGENT LOT NUMBER WAS (B)(4) AND THE TSH REAGENT LOT NUMBER WAS (B)(4). THE EXPIRATION DATES WERE NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 014 YR