BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 2524153 · Received April 9, 2012

    Report

    Report Number
    1823260-2012-01901
    Event Type
    Malfunction
    Date Received
    April 9, 2012
    Date of Event
    March 13, 2012
    Report Date
    May 29, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE WAS PROVIDED FOR INVESTIGATION. THE RESULTS FROM THE E170 ANALYZER INDICATE THE PRESENCE OF A MACROMOLECULAR INTERFERENCE IN THE PATIENT SAMPLE.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE DEHYDROEPIANDROSTERONE SULFATE (DHEA-S) RESULT ON THEIR E-MODULE. THE PATIENT'S INITIAL DHEA-S RESULT WAS 6688 UG/L AND TWICE CONFIRMED. THE PATIENT'S RESULT ON A SIEMENS IMMULITE ANALYZER WAS WITHIN THE NORMAL RANGE, 1400 UG/L. BASED ON THE INFORMATION PROVIDED, THE UNITS OF MEASURE MIGHT BE UG/L, UG/DL, OR MG/DL. CLARIFICATION HAS BEEN REQUESTED. IT IS UNKNOWN IF ANY RESULTS WERE REPORTED OUTSIDE THE LABORATORY. IT IS UNKNOWN IF THE PATIENT WAS ADVERSELY AFFECTED BY THIS EVENT. THE DHEA-S LOT NUMBER WAS 163620 AND THE EXPIRATION DATE WAS NOT PROVIDED.

    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
    1 039 YR YAZ