BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMUNOGLOBULIN E

    MDR report key: 5390208 · Received January 26, 2016

    Report

    Report Number
    1823260-2016-00074
    Event Type
    Malfunction
    Date Received
    January 26, 2016
    Date of Event
    December 24, 2015
    Report Date
    February 18, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JHR
    PMA / PMN Number
    K061970
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS SUBMITTED FOR INVESTIGATION. DURING PRELIMINARY INVESTIGATION, THE CUSTOMER'S HIGH RESULT WAS CONFIRMED. ACCORDING TO PRODUCT LABELING THERE IS NO HIGH-DOSE HOOK EFFECT AT IGE CONCENTRATIONS UP TO 50,000 IU/ML. THIS PATIENT SAMPLE SHOWED IGE RESULTS HIGHER THAN 50,000 IU/ML INDICATING THIS SAMPLE MAY SHOW A HIGH-DOSE HOOK EFFECT.

    Additional Manufacturer Narrative · 0

    THE PATIENT SAMPLE WAS INVESTIGATED FURTHER BY THE SIEMENS CENTAUR METHOD. THE HIGH ROCHE IGE II RESULT WAS ALSO VERIFIED BY THE SIEMENS CENTAUR METHOD BY MEASURING DILUTED SAMPLES. IN A PREVIOUS UPDATE TO THIS REPORT IT WAS NOTED THAT THE PATIENT SAMPLE MAY SHOW A HIGH-DOSE HOOK EFFECT. THIS EFFECT IS ALSO ADDRESSED IN THE PRODUCT LABELING FOR THE SIEMENS CENTAUR METHOD. BASED ON THE AVAILABLE DATA, THE ROCHE IGE II RESULTS ARE CORRECT.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    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 FROM THE MODULAR E ANALYZER WAS 106350 KU/L. THE REPEAT RESULT FROM A SIEMENS CENTAUR INSTRUMENT WAS 420 KU/L. THE IGE FROM AN ELECTROPHORESIS WAS NORMAL. NO ADVERSE EVENT OCCURRED. THE MODULAR E ANALYZER SERIAL NUMBER WAS (B)(4). IT WAS NOTED THAT LIQUID FLOW CLEANING IS PERFORMED EVERY 2 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50045 IMMUNOGLOBULIN E RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E) JHR ROCHE DIAGNOSTICS NA 188637

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Unknown THE PATIENT TAKES NO MEDICATION| THE PATIENT TAKES NO MEDICATION.