BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 4688118 · Received April 14, 2015

    Report

    Report Number
    1823260-2015-02971
    Event Type
    Malfunction
    Date Received
    April 14, 2015
    Date of Event
    March 23, 2015
    Report Date
    May 6, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED ADDITIONAL TSH RESULTS FROM 14 PATIENT SAMPLES. THE SAMPLES WERE COMPARED BETWEEN THE E601 ANALYZER AND AN ARCHITECT ANALYZER. OF THE DATA PROVIDED, 3 PATIENT SAMPLES WERE ERRONEOUS. ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN DID NOT BELIEVE THE RESULTS. PATIENT 1 TSH RESULT WAS 4.55 MIU/L. THE REPEAT RESULT ON THE ARCHITECT WAS 3.46 MIU/L. PATIENT 2 TSH RESULT WAS 7.03 MIU/L. THE REPEAT RESULT ON THE ARCHITECT WAS 5.39 MIU/L. PATIENT 3 TSH RESULT WAS 4.45 MIU/L. THE REPEAT RESULT ON THE ARCHITECT WAS 3.42 MIU/L. NO PATIENTS WERE ADVERSELY AFFECTED. ALL 3 PATIENTS WERE VISITING THE PHYSICIAN FOR A CHECK UP. THE LOCAL APPLICATION SPECIALIST AT THE CUSTOMER SITE FOUND THAT THE INTERNAL QUALITY CONTROLS FOR THE ARCHITECT WERE RUNNING LOW BELOW THE MEAN. BASED ON THE INFORMATION PROVIDED, A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. THE DIFFERENT VALUES BETWEEN THE E601 AND THE ARCHITECT ANALYZER RELATE TO THE DIFFERENT SETUP OF THE ASSAYS.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF HIGH THYROTROPIN (TSH) VALUES IN MULTIPLE PATIENTS WHERE THE CLINICAL DATA INDICATED THE RESULTS SHOULD HAVE BEEN LOWER. THE CUSTOMER COMPLAINS THAT THIS SITUATION OCCURS EVERY DAY WITH SEVERAL SAMPLES. THE CUSTOMER PROVIDED DATA FOR 10 PATIENTS. OF THE DATA PROVIDED, 5 PATIENTS HAD HIGHER THAN EXPECTED TSH RESULTS. OF THE 5 PATIENTS, 1 PATIENT SAMPLE WAS ERRONEOUS. THE INITIAL TSH RESULT WAS 4.72 MIU/L. THE REPEAT RESULT WAS 4.70 MIU/L. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THEY WERE QUESTIONED BY THE PHYSICIAN. THE HIGH RESULTS WERE NOT EXPECTED SINCE OTHER HORMONE TEST RESULTS WERE NORMAL. NO ADVERSE EVENT WAS REPORTED. THE TSH REAGENT LOT NUMBER WAS 183222 WITH AN EXPIRATION DATE OF 09/30/2015. THE LAST PREVENTIVE MAINTENANCE ON THE ANALYZER WAS PERFORMED (B)(6) 2015. THE CALIBRATOR SIGNALS GENERATED BY THE CUSTOMER WERE ON THE LOW END. THE LOCAL APPLICATION SPECIALIST CHANGED THE REAGENT AND CALIBRATOR. AFTER PERFORMING NEW CALIBRATION, THE SIGNALS AND QUALITY CONTROL RESULTS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248857 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 035 YR