BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS IGE II IMMUNOASSAY

    MDR report key: 5080742 · Received September 16, 2015

    Report

    Report Number
    1823260-2015-04177
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    September 2, 2015
    Report Date
    October 23, 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

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    IT WAS STATED THAT A SAMPLE FROM THE PATIENT WAS DILUTED AND MEASURED 3 MONTHS AGO, RESULTING AS 7000 IU/ML FOR IGE. UPON FURTHER INVESTIGATIONS OF THE SAMPLE IN QUESTION, TESTING WAS PERFORMED WITH A DIFFERENT IGE ASSAY USING FEIA METHODOLOGY. THE RESULT OBTAINED WITH THIS ASSAY WAS 10600 IU/ML.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. FURTHER INVESTIGATION OF THE SAMPLE WAS NOT POSSIBLE AS THE VOLUME OF THE SAMPLE WAS NOT SUFFICIENT ENOUGH FOR FURTHER INVESTIGATIONS. A GENERAL REAGENT ISSUE COULD NOT BE DETECTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR IMMUNOGLOBULIN E (IGE). THE SAMPLE RESULTS WERE NOT LINEAR WHEN DILUTING THE SAMPLE. THE SAMPLE INITIALLY RESULTED AS 1902 IU/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS DILUTED TIMES 2 AND REPEATED, RESULTING AS > 4551 IU/ML. THE > 4551 IU/ML VALUE WAS ALSO REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS THEN DILUTED TIMES 10 AND REPEATED, RESULTING AS 7732 IU/ML. THE 7732 IU/ML VALUE WAS ALSO REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS PROVIDED FOR INVESTIGATION, WHERE IT WAS TESTED ON A COBAS 8000 ANALYZER ON (B)(6) 2015. DURING THE INVESTIGATION, THE SAMPLE INITIALLY RESULTED AS 2456 IU/ML. THE SAMPLE WAS THEN REPEATED AT A TIMES 2 DILUTION, RESULTING AS >5000 IU/ML. THE SAMPLE WAS THEN REPEATED AT A TIMES 5 DILUTION, RESULTING AS 7400 IU/ML. THE SAMPLE WAS THEN REPEATED AT A TIMES 10 DILUTION, RESULTING AS 7961 IU/ML. THE SAMPLE WAS ALSO REPEATED AT A TIMES 20 DILUTION, RESULTING AS 8052 IU/ML. THE INVESTIGATION FOUND THAT THE CUSTOMER'S RESULTS WERE REPRODUCIBLE AND NO SIGNS OF INTERFERENCE WERE NOTED. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE PATIENT WAS ADVERSELY AFFECTED. NO ADVERSE EVENTS WERE ALLEGED. THE SERIAL NUMBER OF THE E602 ANALYZER USED AT THE CUSTOMER SITE WAS ASKED FOR, BUT NOT PROVIDED. IGE REAGENT LOT NUMBER 181429, WITH AN EXPIRATION DATE OF JUNE 2016 WAS USED ON THE COBAS 8000 ANALYZER WHICH WAS USED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612934 ELECSYS IGE II IMMUNOASSAY RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E) JHR ROCHE DIAGNOSTICS NA 181429

    Patients

    Seq Age Sex Outcome Treatment
    1 083 YR