BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS IGE II IMMUNOASSAY

    MDR report key: 4479822 · Received February 3, 2015

    Report

    Report Number
    1823260-2015-00814
    Event Type
    Malfunction
    Date Received
    February 3, 2015
    Date of Event
    January 13, 2015
    Report Date
    April 14, 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 NEW SAMPLE WAS DRAWN FROM THE PATIENT AND THE SAME PHENOMENON WAS OBSERVED. ON (B)(6) 2015, THE ORIGINAL IMMUNOGLOBULIN E (IGE) RESULT WAS 1511 IU/ML. WITH A 1:10 DILUTION, THE RESULT WAS 8313 IU/ML. THIS SAMPLE WAS SUBMITTED FOR FURTHER INVESTIGATION. THE PATIENT WAS INJECTED WITH "XOLAIR (OMALIZUMAB, ANTI-HUMAN IGE ANTIBODY, NOVARTIS)" FOR "RUSH ORAL IMMUNOTHERAPY."

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED AS INSUFFICIENT PATIENT SAMPLE WAS AVAILABLE FOR FURTHER INVESTIGATION. THE TESTING EXCLUDED A LINEARITY ISSUE OR A "HOOK EFFECT" IN THE SAMPLE. INTERFERENCE WAS SUSPECTED, BUT COULD NOT BE CONFIRMED. THE PROVIDED ANALYZER PERFORMANCE DATA WAS WITHIN SPECIFICATION AND DID NOT INDICATE A SPECIFIC ISSUE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION CONCERNING THE PATIENT WAS PROVIDED. THE PATIENT'S HEIGHT WAS (B)(6). THE PATIENT WAS GIVEN 525 MG OF XOLAIR ONCE EVERY 2 WEEKS.

    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 E (IGE) RESULTS FOR ONE PATIENT SAMPLE. THE ORIGINAL SAMPLE RESULT WAS 1519.0 IU/ML. THE SAMPLE WAS TESTED WITH DILUTIONS AND THE RESULTS WERE 6537.0 IU/ML (1:5), 8183.0 IU/ML (1:10) AND 9156.0 IU/ML (1:50). INFORMATION CONCERNING WHICH RESULT WAS REPORTED OUTSIDE THE LABORATORY WAS REQUESTED, BUT WAS NOT PROVIDED. THERE WAS NO ADVERSE EVENT REPORTED. THE IGE REAGENT LOT NUMBER WAS 175624. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED. SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION AND THE CUSTOMER'S RESULTS WERE REPRODUCED. BASED ON THE PROVIDED CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE WAS EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78563 ELECSYS IGE II IMMUNOASSAY RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E) JHR ROCHE DIAGNOSTICS NA 175624

    Patients

    Seq Age Sex Outcome Treatment
    1 013 YR