BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS IGE II IMMUNOASSAY

    MDR report key: 7500070 · Received May 9, 2018

    Report

    Report Number
    1823260-2018-01424
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    March 28, 2018
    Report Date
    July 24, 2018
    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 · 0

    SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION AND AN INCREASED LEVEL OF IGE-IGG COMPLEXES WAS DETECTED. THIS INDICATES THAT ANTI-IGE IGG ANTIBODIES WERE PRESENT IN THE SAMPLE. PRODUCT LABELING FOR THE ASSAY STATES NOT TO USE THE ASSAY FOR PATIENTS UNDER TREATMENT WITH DRUGS CONTAINING ANTI-IGE ANTIBODIES. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE. A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PERFORMED THE AUTOMATIC DILUTIONS OF THE SAMPLE TO DETECT HETEROANTIBODIES. NEW DATA WAS PROVIDED AND THE IGE II RESULT WAS 8095 IU/ML WITH A X400 DILUTION ON THE DAY OF THE EVENT. THE IGE INVESTIGATION RESULT >2500 IU/ML WITH A DATA FLAG WHEN CALCULATED USING THE RESULTS SIGNAL WAS 3200 IU/ML. UPON FURTHER INVESTIGATION WITH THE SAMPLE. THE IGE RESULT WAS 11493 IU/ML WITH A X10 DILUTION USING THE IMMUNOCAP METHOD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF DISCREPANT ELECSYS IGE II IMMUNOASSAY RESULTS ON A COBAS 8000 E 602 MODULE SERIAL NUMBER (B)(4). REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THE CUSTOMER INITIALLY RAN THE SAMPLE ON THE E 602 ANALYZER WITH MULTIPLE DILUTIONS. THE CUSTOMER COMPLAINED THE DILUTION RESULTS WERE NOT LINEAR. THE CUSTOMER PROVIDED THE SAMPLE FOR INVESTIGATION WHERE IT WAS TESTED USING THE SAME DILUTIONS. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342164 ELECSYS IGE II IMMUNOASSAY RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E) JHR ROCHE DIAGNOSTICS NA 266289

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR WARFARIN