BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 4695018 · Received April 15, 2015

    Report

    Report Number
    1823260-2015-03048
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    March 19, 2015
    Report Date
    April 15, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS HIGH RESULTS FOR 7 PATIENT SAMPLES TESTED FOR FREE THYROXINE (FT4). THE SPECIFIC FT4 RESULTS OF 4 PATIENTS TESTED ON THE E601 ANALYZER WERE PROVIDED. THE SPECIFIC RESULTS FOR THE OTHER 3 PATIENT SAMPLES HAVE BEEN REQUESTED. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. PATIENT SAMPLE 1 INITIAL FT4 RESULT WAS 77.3 PMOL/L. THE SAMPLE WAS SENT TO A SISTER LAB ON (B)(6) 2015 AND TESTED ON AN ABBOTT ANALYZER WHERE THE REPEAT RESULT WAS "NORMAL." THE ACTUAL RESULT HAS BEEN REQUESTED. PATIENT SAMPLE 2 INITIAL FT4 RESULT WAS 100 PMOL/L. THE SAMPLE WAS SENT TO A SISTER LAB ON (B)(6) 2015 AND TESTED ON AN ABBOTT ANALYZER WHERE THE REPEAT RESULT WAS 29.7 PMOL/L. PATIENT SAMPLE 3 INITIAL FT4 RESULT WAS 70.9 PMOL/L. THE SAMPLE WAS SENT TO A SISTER LAB ON (B)(6) 2015 AND TESTED ON AN ABBOTT ANALYZER WHERE THE REPEAT RESULT WAS "NORMAL." THE ACTUAL RESULT HAS BEEN REQUESTED. PATIENT SAMPLE 4 INITIAL FT4 RESULT WAS 100 PMOL/L. THE SAMPLE WAS SENT TO A SISTER LAB ON (B)(6) 2015 AND TESTED ON AN ABBOTT ANALYZER WHERE THE REPEAT RESULT WAS "NORMAL." THE ACTUAL RESULT HAS BEEN REQUESTED. NO ADVERSE EVENTS WERE REPORTED. THE CUSTOMER INDICATED THAT ALL 4 OF THESE PATIENTS ARE FINE AND NO TREATMENT WAS ADMINISTERED. THE CUSTOMER INDICATED THAT THE ORIGINAL SAMPLE WAS RUN AGAIN ON THE COBAS E601 ANALYZER ON (B)(6) 2015 AND THE RESULTS WERE NORMAL. THE TSH RESULTS FOR ALL PATIENT SAMPLES WERE NORMAL ON BOTH THE E601 ANALYZER AND THE ABBOTT ANALYZER FROM THE SISTER LAB. THE CUSTOMER HAS ALSO RUN CKMB, TNT HSS, BHCG AND THOSE RESULTS ARE ACCEPTABLE. THE FT4 REAGENT LOT NUMBER WAS 181732 WITH AN EXPIRATION DATE OF 01/29/2016. PINCH VALVE TUBING WAS REPLACED ON (B)(6) 2015. MAINTENANCE WAS PERFORMED ON (B)(6) 2015. THE FT4 REAGENT WAS REPLACED ON (B)(6) 2015. THE REAGENT ON BOARD WAS INSPECTED AND MAGNETIC BEADS WERE DISCOVERED TO BE STUCK ON THE LID. MEASURING CELLS WERE CHANGED ON (B)(6) 2015. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE ERRONEOUS HIGH FT4 VALUES WERE MOST LIKELY CAUSED BY INCORRECT REAGENT HANDLING AS MAGNETIC BEADS WERE OBSERVED IN THE COMPARTMENT LID OF THE FT4 REAGENT PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250974 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PATIENT 3 - NONE| PATIENT 4 - NONE| PATIENT 1 - NONE| PATIENT 2 - NONE