BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS IGE II

    MDR report key: 17362987 · Received July 20, 2023

    Report

    Report Number
    1823260-2023-02366
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    July 1, 2023
    Report Date
    September 1, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JHR
    UDI-DI
    04015630922369
    PMA / PMN Number
    K061970
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALIBRATION SIGNALS WERE WITHIN EXPECTATIONS. QUALITY CONTROLS PERFORMED ON 29-JUN-2023 AND ON 03-JUL-2023 WERE WITHIN RANGE. THE CUSTOMER DID NOT RUN CONTROLS ON THE DAY OF THE EVENT BASED ON THE PROVIDED INFORMATION. UPON REVIEW OF THE ALARM TRACE, NO RELEVANT ALARMS WERE OBSERVED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE COBAS 6000 E601 MODULE IS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS IGE II ON A COBAS 6000 E601 MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN IGE VALUE OF 0.195 UI/ML ACCOMPANIED BY A DATA FLAG INDICATING CARRYOVER. THERE WERE ONLY 3 TESTS REMAINING IN THE REAGENT PACK DURING THIS MEASUREMENT. THE SAMPLE WAS REPEATED, RESULTING IN AN IGE VALUE OF 958.2 UI/ML. THIS MEASUREMENT WAS PERFORMED USING A NEW REAGENT PACK. AN ADDITIONAL IGE VALUE OF < 0.100 UI/ML WITH A DATA FLAG WAS PROVIDED. IT WAS ASKED, BUT IT IS NOT KNOWN IF THIS IS AN ADDITIONAL REPEAT VALUE FROM THE COMPLAINED SAMPLE OR IF IT IS A RESULT OF A DIFFERENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124045 ELECSYS IGE II RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D,E) JHR ROCHE DIAGNOSTICS NA 67239400 04015630922369

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Unknown