BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS IGE II

    MDR report key: 19321624 · Received May 15, 2024

    Report

    Report Number
    1823260-2024-01454
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    April 23, 2024
    Report Date
    May 29, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JHR
    UDI-DI
    04015630922369
    PMA / PMN Number
    K061970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS E411 RACK SERIAL NUMBER WAS (B)(6). THE CALIBRATION AND QC RESULTS WERE WITHIN SPECIFICATIONS. PREVENTIVE MAINTENANCE WAS PERFORMED AND THE SAMPLE/REAGENT PROBE AND SIPPER PROBE ADJUSTMENTS WERE CHECKED ALONG WITH THE BEAD MIXER FUNCTION, PHOTOMULTIPLIER HIGH VOLTAGE, BLANKCELL CALIBRATION AND PERFORMANCE TESTING.

    Additional Manufacturer Narrative · 0

    DATA WAS PROVIDED FOR AN ADDITIONAL PATIENT SAMPLE WITH QUESTIONABLE ELECSYS IGE II RESULTS FROM THE COBAS E411 RACK ANALYZER. ON (B)(6) 2024, THE INITIAL RESULT WAS 1.04 IU/ML AND THE REPEAT RESULT WAS 14.74 IU/ML. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. A GENERAL REAGENT PROBLEM WAS NOT PRESENT, BECAUSE THE QC PRIOR TO THE EVENT WAS WITHIN RANGES.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS IGE II RESULTS FROM THE COBAS E411 RACK ANALYZER. THE INITIAL RESULT WAS 0.931 IU/ML AND THE REPEAT RESULT WAS 589.9 IU/ML WITH A DATA FLAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483969 ELECSYS IGE II RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D,E) JHR ROCHE DIAGNOSTICS 762905 04015630922369

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown