BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 5988673 · Received September 29, 2016

    Report

    Report Number
    1823260-2016-01493
    Event Type
    Malfunction
    Date Received
    September 29, 2016
    Date of Event
    September 16, 2016
    Report Date
    September 29, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS TSH ASSAY RESULTS FOR ONE PATIENT. ON (B)(6) 2016, THE RESULT WAS 7.49 UIU/ML AND THE REPEAT RESULT ON ANOTHER ANALYZER WAS 7.60 UIU/ML. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY AND WAS QUESTIONED BY THE PATIENT. ON (B)(6) 2016, A NEW SAMPLE WAS DRAWN AND THE RESULT WAS 3.85 UIU/ML. ON (B)(6) 2016, THE TWO SAMPLES WERE MEASURED BY LIAISON METHOD AND THE RESULT FOR THE FIRST SAMPLE WAS 7.41 UIU/ML AND THE RESULT FOR THE SECOND SAMPLE WAS 3.65 UIU/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 143583. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. AS THE RESULTS FOR BOTH SAMPLES TESTED WITH THE DIFFERENT METHODOLOGIES WERE VERY SIMILAR, A RANDOM EVENT WAS NOT SUSPECTED. THE INVESTIGATION FOUND THE PROVIDED CALIBRATION DATA WAS ACCEPTABLE AND QC RESULTS WERE WITHIN SPECIFICATIONS. NO GENERAL REAGENT ISSUE COULD BE FOUND. THE MEDICATIONS TAKEN BY THE PATIENT CONTAIN BIOTIN. HOWEVER, AS THE DIASORIN (LIAISON) ASSAY DOES NOT USE A STREPTAVIDIN-BIOTIN COMPLEXING SYSTEM AND AS THE RESULTS RECEIVED FOR BOTH SAMPLES WERE SIMILAR, THE BIOTIN WAS NOT LIKELY THE ROOT CAUSE OF THE EVENT. POSSIBLE CAUSES INCLUDE KNOWN PHYSIOLOGICAL AND PATHOPHYSIOLOGICAL CONDITIONS THAT MAY ALTER THE TSH SECRETION PATTERN IN THE PATIENT SUCH AS ACUTE SLEEP WITHDRAWAL, ACUTE STRESS, OR HIGH PHYSICAL ACTIVITY. ANOTHER POSSIBLE CAUSE COULD BE CONTAMINATION OF THE SAMPLE FROM SPLASHES FROM OTHER SAMPLES OR CALIBRATOR SOLUTIONS, OR FROM THE CUSTOMER HANDLING OF LYOPHILISATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637597 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR KORPUSLIFE| MAXITABS HAIR| OMEGA 3