BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS IGE II

    MDR report key: 17475403 · Received August 7, 2023

    Report

    Report Number
    1823260-2023-02553
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    July 10, 2023
    Report Date
    September 1, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JHR
    UDI-DI
    04015630922369
    PMA / PMN Number
    K061970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE SAMPLE PIPETTE WAS VERY CLOSE TO THE WALL OF THE SAMPLE TUBES AND MADE ADJUSTMENTS. IT WAS FOUND THAT THE CUSTOMER WAS NOT USING RACK ADAPTERS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC DATA PROVIDED WAS ACCEPTABLE. THE ALARM TRACE SHOWED MULTIPLE SAMPLE QUALITY ALARMS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS IGE II RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E601 MODULE. THE INITIAL IGE RESULT WAS 134.5 IU/ML. THE SAMPLE WAS REPEATED AS THE INITIAL RESULT WAS OUTSIDE OF THE REFERENCE RANGE. THE REPEAT RESULT WAS 1.02 IU/ML AND THE SECOND REPEAT RESULT WAS 147.5 IU/ML. THE SECOND REPEAT RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337416 ELECSYS IGE II RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D,E) JHR ROCHE DIAGNOSTICS 67239400 04015630922369

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Unknown