BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS IGE II IMMUNOASSAY

    MDR report key: 16727964 · Received April 12, 2023

    Report

    Report Number
    1823260-2023-01238
    Event Type
    Malfunction
    Date Received
    April 12, 2023
    Date of Event
    March 14, 2023
    Report Date
    May 18, 2023
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT USE RACK/DISK ADAPTERS FOR THE 13MM 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. R ALWAYS USE ROCHE RACK CUP ADAPTERS WITH 13 MM TUBES. ENSURE THAT SAMPLE TUBES ARE STRAIGHT." THE CLOTTING TIME WAS 7-10 MINUTES. THE MINIMUM CLOTTING TIME FOR MOST TUBE MANUFACTURERS IS 30 MINUTES. THE ALARM TRACE ON 14-MAR-2023 SHOWED "ASSAY REAGENT HOVERING (LIQUID LEVEL MISDETECTED DUE TO STATIC ELECTRICITY OR FILM)". THIS INDICATES THAT THERE MIGHT BE FILM PRESENT ON THE REAGENT. THE INVESTIGATION DID NOT IDENTIFY A REAGENT PROBLEM. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS IGE II IMMUNOASSAY RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 411 IMMUNOASSAY ANALYZER. ON (B)(6) 2023, PATIENT 1 HAD AN INITIAL IGE RESULT OF 1.6 IU/ML. THE REPEAT RESULT WAS 93.0 IU/ML. PATIENT 2 HAD AN INITIAL IGE RESULT OF 1.5 IU/ML. THE REPEAT RESULT WAS 141.2 IU/ML. THE PATIENT SAMPLES WERE SENT FOR INVESTIGATION. ON (B)(6) 2023, THE PATIENTS' SAMPLES WERE TESTED AT AN INVESTIGATIONAL LABORATORY. FOR PATIENT 1, THE INITIAL UNDILUTED RESULTS WERE 92.72 IU/ML, 94.54 IU/ML, AND 91.08 IU/ML. A 1:2 DILUTION WAS MADE AND THE RESULT WAS 83.48 IU/ML. A 1:5 DILUTION WAS MADE AND THE RESULT WAS 75.90 IU/ML. A 1:10 DILUTION WAS MADE AND THE RESULT WAS 77.42 IU/ML. FOR PATIENT 2, THE INITIAL UNDILUTED RESULTS WERE 137.8 IU/ML, 135.1 IU/ML, AND 137.2 IU/ML. A 1:2 DILUTION WAS MADE AND THE RESULT WAS 130.6 IU/ML. A 1:5 DILUTION WAS MADE AND THE RESULT WAS 115.9 IU/ML. A 1:10 DILUTION WAS MADE AND THE RESULT WAS 115.8 IU/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE ANALYZER SERIAL NUMBER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349088 ELECSYS IGE II IMMUNOASSAY IMMUNOGLOBULIN E ASSAY JHR ROCHE DIAGNOSTICS IGE II 619033

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male BENRALIZUMAB (PATIENT 1)| DULOXETINE CAPSULES (PATIENT 2)| EFFEXOR SR CAPSULES (PATIENT 2)| FELBINAC (PATIENT 2)| FLUNITRAZEPAM (FLUNITRAZEPAM) (PATIENT 2)| LATUDA (LURASIDONE HYDROCHLORIDE) (PATIENT 2)| LORAZEPAM (PATIENT 2)| LOXOPROFEN TAPE (PATIENT 2)| MOHRUS PAPS (KETOPROFEN) (PATIENT 2)| NEUROTROPIN (PATIENT 2)| QUETIAPINE (QUETIAPINE FUMARATE) (PATIENT 2)| RISPERIDONE (PATIENT 2)| SERTRALINE (SERTRALINE HYDROCHLORIDE) (PATIENT 2)| TOARASET COMBINATION TAB (PATIENT 2)