BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMUNOGLOBULIN E

    MDR report key: 5532914 · Received March 29, 2016

    Report

    Report Number
    1823260-2016-00369
    Event Type
    Malfunction
    Date Received
    March 29, 2016
    Date of Event
    February 25, 2016
    Report Date
    May 23, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JHR
    PMA / PMN Number
    K061970
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE WAS SUBMITTED FOR INVESTIGATION. DURING THE INVESTIGATION THE CUSTOMER'S RESULTS WERE REPRODUCED. THE VERY HIGH IGE II RESULTS CAUSES A HIGH DOSE HOOK EFFECT AS DESCRIBED IN PRODUCT LABELING. BASED ON THE INVESTIGATION DATA, A GENERAL REAGENT ISSUE CAN BE EXCLUDED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT SAMPLE TESTED FOR IMMUNOGLOBULIN E (IGE II). IT IS NOT KNOWN IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL IGE II RESULT WAS 925.00 IU/ML. THE SAMPLE WAS DILUTED X5 AND THE RESULT WAS >12,500.00 IU/ML. THE SAMPLE WAS DILUTED X400 AND THE RESULT WAS 163,623.00 IU/ML. NO ADVERSE EVENT OCCURRED. THE E602 ANALYZER SERIAL NUMBER WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189450 IMMUNOGLOBULIN E RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D,E) JHR ROCHE DIAGNOSTICS IGE 181429

    Patients

    Seq Age Sex Outcome Treatment
    1