BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS IGE II IMMUNOASSAY

    MDR report key: 6604794 · Received June 1, 2017

    Report

    Report Number
    1823260-2017-01123
    Event Type
    Malfunction
    Date Received
    June 1, 2017
    Date of Event
    May 10, 2017
    Report Date
    August 17, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JHR
    PMA / PMN Number
    K061970
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION AND AN INCREASED LEVEL OF IGE-IGG COMPLEXES WAS DETECTED. THIS MOST LIKELY CAUSED THE REDUCED DETECTION OF IGE IN THE UNDILUTED SAMPLE. THESE COMPLEXES MAY RESULT FROM AN AUTO-IMMUNE DISEASE AND/OR MAY BE REMNANTS OF A TERMINATED ANTI-ALLERGY OR ANTI-ASTHMA THERAPY. PRODUCT LABELING FOR THE ASSAY STATES NOT TO USE THE ASSAY FOR PATIENTS UNDER TREATMENT WITH XOLAIR OR SIMILAR DRUGS CONTAINING ANTI-IGE ANTIBODIES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE ELECSYS IGE II IMMUNOASSAY RESULT FOR ONE PATIENT SAMPLE. THE CUSTOMER USED COBAS 8000 E 602 MODULE SERIAL NUMBER (B)(4). THE INITIAL RESULT FOR THIS SAMPLE WAS 991.7 IU/ML. THE DOCTOR DID NOT AGREE WITH THE RESULT AS IT WAS NOT CONSISTENT WITH THE MEDICAL HISTORY. THIS PATIENT NORMALLY HAD A RESULT OF 21000 UI/ML. THE CUSTOMER PERFORMED DILUTIONS OF THE SAMPLE AS FOLLOWS: 1:5 DILUTION RESULT WAS 4569 IU/ML. A 1:10 DILUTION RESULT WAS 12609 IU/ML. A 1:50 DILUTION RESULT WAS 20333 IU/ML. A 1:100 DILUTION RESULT WAS 21548 IU/ML. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385379 ELECSYS IGE II IMMUNOASSAY RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D,E) JHR ROCHE DIAGNOSTICS IGE 17305400

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR