BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS IGE II

    MDR report key: 17887100 · Received October 6, 2023

    Report

    Report Number
    1823260-2023-03218
    Event Type
    Malfunction
    Date Received
    October 6, 2023
    Date of Event
    September 12, 2023
    Report Date
    November 6, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JHR
    UDI-DI
    04015630922369
    PMA / PMN Number
    K061970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER REPLACED THE PINCH VALVES. ON HIS SECOND SERVICE VISIT, HE PERFORMED MECHANICAL AND INSTRUMENT CHECKS. THE INVESTIGATION NOTED THAT THE CUSTOMER DOES NOT USE RACK ADAPTERS FOR THE 13 MM SAMPLE TUBES. PRODUCT LABELING STATES "INSERTING A ROCHE RACK CUP ADAPTER INTO A RACK - USE ROCHE RACK CUP ADAPTERS TO IMPROVE THE ALIGNMENT OF 13 MM TUBES. WARNING ! INCORRECT RESULTS AND ERRORS DUE TO MISALIGNED SAMPLE TUBES NOT USING A ROCHE RACK CUP ADAPTER WITH 13 MM TUBES OR INCORRECT USE OF A ROCHE RACK CUP ADAPTER MAY CAUSE INCORRECT RESULTS OR ERRORS. ALWAYS USE ROCHE RACK CUP ADAPTERS WITH 13 MM TUBES. ENSURE THAT SAMPLE TUBES ARE STRAIGHT." THE INVESTIGATION REVIEWED THE CALIBRATION DATA AND NOTED THAT THE CALIBRATION SIGNALS MAY BE LOWER THAN EXPECTED. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE CUSTOMER'S COBAS E411 DISK IS (B)(6). THE FIELD SERVICE ENGINEER PERFORMED PREVENTIVE MAINTENANCE ON THE ANALYZER. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS IGE II RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E411 DISK. THE INITIAL RESULT WAS 405.1 NG/ML. THE REPEAT RESULT WAS 253.2 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307192 ELECSYS IGE II RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D,E) JHR ROCHE DIAGNOSTICS 619033 04015630922369

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female