BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMUNOGLOBULIN E

    MDR report key: 4542108 · Received February 24, 2015

    Report

    Report Number
    1823260-2015-01504
    Event Type
    Malfunction
    Date Received
    February 24, 2015
    Date of Event
    February 9, 2015
    Report Date
    April 15, 2015
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE FROM THE PATIENT WAS INVESTIGATED AND THE CUSTOMER'S RESULTS WERE CONFIRMED. THE PATIENT WAS INJECTED WITH XOLAIR (OMALIZUMAB, ANTI-HUMAN IGE ANTIBODY, NOVARTIS) FOR "RUSH ORAL IMMUNOTHERAPY."

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE PATIENT. THE PATIENT'S HEIGHT WAS (B)(6). THE PATIENT WAS TAKING 300 MG/DAY OF XOLAIR ONCE EVERY TWO WEEKS FROM (B)(6) 2014 THROUGH CURRENT DAY.

    Additional Manufacturer Narrative · 1

    AS PART OF THE INVESTIGATION, XOLAIR WAS ADDED TO HUMAN IGE SAMPLES AND THE RESULTS COMPARED WITH A DRUG FREE CONTROL SAMPLE. THE SPIKED SAMPLES SHOWED REDUCED RECOVERY OF IGE. A PHARMACOLOGICAL INTERFERENCE WITH THE ASSAY WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE IMMUNOGLOBULIN (IGE) RESULTS FOR ONE PATIENT SAMPLE FROM AN UNKNOWN ROCHE ANALYZER. ORIGINAL FIRST RESULT WAS 1701.0 IU/ML, REPEAT RESULT WAS 1799.0 IU/ML. AUTO DILUTION 1:5 RESULT WAS 938.4 IU/ML (CALCULATED 4692.0 IU/ML). AUTO DILUTION 1:10 RESULT WAS 509.8 IU/ML (CALCULATED 5098.0 IU/ML). MANUAL DILUTION 1:50 RESULT WAS 113.8 IU/ML (CALCULATED 5690 IU/ML). INFORMATION CONCERNING WHICH RESULT WAS REPORTED OUTSIDE THE LABORATORY OR IF THE PATIENT WAS ADVERSELY AFFECTED WAS REQUESTED, BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129743 IMMUNOGLOBULIN E RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E) JHR ROCHE DIAGNOSTICS NA 175624

    Patients

    Seq Age Sex Outcome Treatment
    1 008 YR