BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1920015 · Received December 10, 2010

    Report

    Report Number
    1823260-2010-07358
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 14, 2010
    Report Date
    February 1, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED INFORMATION STATING THEY MADE A MISTAKE AND THE TSH RESULTS OF 91 UIU/ML REPORTED IN INITIAL MEDWATCH DID NOT EXIST. NEW INFORMATION WAS ALSO RECEIVED REGARDING THE TSH RESULTS. REPEAT TESTING WAS PERFORMED ON THESE SAMPLES. THE REPEAT RESULTS WERE "ALMOST THE SAME". THE EXACT VALUES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. THE SAMPLE WAS TESTED AND THE RESULTS THE CUSTOMER RECEIVED WERE VERIFIED. THE ELEVATED TSH RESULT WAS FURTHER CONFIRMED USING THE SEIMENS CENTAUR METHOD. NO KNOWN INTERFERENCE FACTOR WAS IDENTIFIED IN THE PATIENT SAMPLE. THE TSH VALUE OBTAINED WITH ELECSYS REAGENT IS VALID AND DOES NOT POINT TO ANY ISSUE WITH THE ELECSYS REAGENTS.

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE HIGH THYROTROPIN (TSH) RESULT ON THE ANALYTICAL E MODULE WHICH DOES NOT FIT WITH THE CLINICAL PICTURE OF THE PATIENT. THE INITIAL RESULT WAS 91 UIU/ML, EXACT DATE OF TESTING WAS NOT PROVIDED FOR THIS SAMPLE. THE TSH RESULT OF 91 UIU/ML WAS REPORTED OUTSIDE THE LABORATORY AND THE DOCTOR QUESTIONED THIS RESULT AS HE EXPECTED THE CORRECT TSH RESULT FOR THIS PATIENT WAS 1 UIU/ML. THE USER SAID THE SAMPLE REPEATED THE SAME TSH RESULT. THIS REPEAT TSH RESULT WAS NOT PROVIDED. NO ADVERSE EVENT HAS BEEN ALLEGED REGARDING THIS EVENT. THE REAGENT LOT NUMBER FOR TSH WAS 159316.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR