BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KIT (SPE)

    MDR report key: 15526096 · Received October 1, 2022

    Report

    Report Number
    1219913-2022-00333
    Event Type
    Malfunction
    Date Received
    October 1, 2022
    Date of Event
    July 20, 2022
    Report Date
    December 28, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    DHB
    PMA / PMN Number
    K101572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER AND REPORTED THAT A FALSE NEGATIVE 3GALLERGY SPECIFIC IGE (SPE) EGG ALLERGEN (F245) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. SPE ADJUSTMENTS AND CONTROLS WERE REVIEWED. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE COLLECTED THE INSTRUMENT MAINDATABASE, ERROR LOG AND SPYFILES. THE LIMITATIONS SECTION OF THE 3GALLERGY SPECIFIC IGE INSTRUCTIONS FOR USE (IFU) STATES: "A DEFINITIVE CLINICAL DIAGNOSIS SHOULD NOT BE MADE SOLELY ON THE BASIS OF AN IN VITRO ALLERGEN-SPECIFIC IGE RESULT. DIAGNOSIS SHOULD BE MADE BY THE PHYSICIAN ONLY AFTER ALL CLINICAL AND LABORATORY FINDINGS HAVE BEEN EVALUATED." "IN VITRO ALLERGEN-SPECIFIC IGE RESULTS SHOULD NOT BE USED AS A DEFINITIVE GUIDE TO SELECTING AN INITIAL DOSE FOR IMMUNOTHERAPY." THE 510K NUMBER OF THIS REPORT (K101572) IS FOR THE SIMILAR PRODUCT THAT IS REGISTERED IN THE UNITED STATES (CATALOG NUMBER 10708840). SIEMENS IS INVESTIGATING.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED MDR 1219913-2022-00333 INITIAL REPORT ON 2022-10-01. ADDITIONAL INFORMATION - 2022-12-06. SIEMENS CONCLUDED INVESTIGATION FOR AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER OBSERVATION OF A FALSE NEGATIVE 3GALLERGY SPECIFIC IGE (SPE) EGG ALLERGEN (F245) RESULT OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT (SERIAL NUMBER H2103). THE SAMPLE WAS INITIALLY TESTED ON 2022-07-20 AND RESULTED AS <0.10 KU/L (CLASS 0, ABSENT). THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT, AND THE SAMPLE WAS RUN AGAIN ON 2022-07-22 WITH A RESULT OF 5.70 KU/L (CLASS IV, VERY HIGH). SIEMENS REVIEWED THE PROVIDED DATA, WHICH INDICATES SIGNIFICANTLY ERRATIC REAGENT LEVEL SENSING WITHIN THE SPE ALLERGY REAGENT WEDGE WHICH COULD BE INDICATIVE OF FOAM OR BUBBLES. BASED ON THIS REAGENT LEVEL SENSING DATA, THERE IS POTENTIAL THAT REAGENT LEVEL SENSING ISSUES CONTRIBUTED TO THE QUESTIONABLE RESULT HOWEVER, THIS IS INCONCLUSIVE. THE ISSUE OCCURRED ON A SINGLE PATIENT SAMPLE RESULT THEREFORE, PRE-ANALYTICAL SAMPLE VARIABLES CANNOT BE RULED OUT. BASED ON THE INVESTIGATION, A POTENTIAL PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. IN SECTION H6, INVESTIGATION FINDING AND INVESTIGATION CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    A FALSE NEGATIVE 3GALLERGY SPECIFIC IGE (SPE) EGG ALLERGEN (F245) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED BECAUSE THE OTHER ALLERGENS OF EGG COMPONENTS WERE POSITIVE. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULT RECOVERED AS POSITIVE. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN AS THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE NEGATIVE SPE F245 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2384066 IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KIT (SPE) ALLERGY IMMUNOASSAY DHB SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED N/A 841

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO Female