BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS IGE II IMMUNOASSAY

    MDR report key: 7376739 · Received March 28, 2018

    Report

    Report Number
    1823260-2018-00925
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    March 6, 2018
    Report Date
    April 25, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JHR
    PMA / PMN Number
    K061970
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION AND THE CUSTOMER'S RESULTS WERE REPRODUCED. PER PRODUCT LABELING, THE CUSTOMER IS INSTRUCTED TO NOT TEST SAMPLES FROM PATIENTS UNDER TREATMENT WITH XOLAIR (OMALIZUMAB) OR SIMILAR DRUGS CONTAINING ANTI-IGE ANTIBODIES DUE TO INTERFERENCE. NO REAGENT ISSUE COULD BE IDENTIFIED AND IT WAS CONFIRMED THE REAGENT PERFORMED WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)#: (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS IGE II IMMUNOASSAY RESULTS FOR ONE PATIENT FROM A ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER. THE SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. ON AN UNKNOWN DATE, THE FIRST SAMPLE FROM THE PATIENT HAD A RESULT OF APPROXIMATELY 900 U/ML. THIS RESULT WAS REPORTED THE TO THE PATIENT. SOME DAYS LATER, THE PATIENT WAS REDRAWN AND TESTED IN ANOTHER LABORATORY (EMICAP) AND THE RESULT WAS APPROXIMATELY 10000 U/ML. ON (B)(6) 2018, THE PATIENT WAS REDRAWN AND TESTED ON THE ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER. THE RESULT FROM A TUBE WITH GEL WAS 765.7 U/ML WITH A DATA FLAG AND THE RESULT FROM A TUBE WITHOUT GEL WAS 865.8 U/ML WITH A DATA FLAG. WITH A 1:20 DILUTION, THE RESULT WAS 9589 U/ML AND WITH A 1:50 DILUTION, THE RESULT WAS 9828 U/ML. THE RESULT OF 865.8 U/ML WITH A DATA FLAG WAS REPORTED OUTSIDE OF THE LABORATORY. THE RESULT FROM THE OTHER LABORATORY WAS BELIEVED TO BE CORRECT FOR THE PATIENT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222930 ELECSYS IGE II IMMUNOASSAY RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D,E) JHR ROCHE DIAGNOSTICS IGE 266289

    Patients

    Seq Age Sex Outcome Treatment
    1 XOLAIR