BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 3GALLERGY SPECIFIC IGE

    MDR report key: 7533663 · Received May 22, 2018

    Report

    Report Number
    2432235-2018-00207
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    April 24, 2018
    Report Date
    July 20, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    DHB
    UDI-DI
    00630414959788
    PMA / PMN Number
    K013134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR 2432235-2018-00207 WAS FILED ON 22-MAY-2018. ADDITIONAL INFORMATION (04-JUN-2018): THE KIT LOT USED TO TEST THE PATIENT SAMPLE IN QUESTION FOR 3GALLERGY SPECIFIC IGE, RAT EPITHELIUM ALLERGEN (E73) WAS LOT 601. UPON FURTHER REVIEW OF DATA, SIEMENS DETERMINED THAT ALLERGENS FROM THE SAME GENUS ARE EXPECTED TO CROSS-REACT AS IN THE CASE OF RATTUS RATTUS (BLACK RATS) AND RATTUS NORVEGICUS (BROWN RATS). SECTIONS B5 AND D4 HAVE BEEN UPDATED WITH THE ADDITIONAL INFORMATION. MDR 2432235-2018-00206_S1 HAS BEEN FILED FOR THE SAME EVENT FOR ALLERGEN E87 WHICH HAS DIFFERENT 510(K) # OF K021206.

    Description of Event or Problem · 0

    DISCORDANT, FALSE NEGATIVE 3GALLERGY SPECIFIC IGE RESULT FOR RAT EPITHELIUM ALLERGEN (E73) (510 (K) # K013134) WAS OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT, WHILE USING KIT LOT 601.

    Additional Manufacturer Narrative · 1

    A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE KIT RELEASE DATA FOR THE LATEST LOT (KIT LOT 602) AVAILABLE FOR IMMULITE 2000 3GALLERGY SPECIFIC IGE RESULTS FOR RAT EPITHELIUM ALLERGEN (E73), WHICH SHOWED THAT THE ALLERGEN IS PERFORMING AS EXPECTED. THE HSC SPECIALIST CONCLUDED THAT THE POTENTIAL CAUSE OF THE DISCORDANT RESULTS COULD BE DUE TO THE SAMPLE SPECIFIC ISSUE. THE DEVICE IS PERFORMING AS EXPECTED. NO FURTHER EVALUATION OF DEVICE IS REQUIRED. MDR 2432235-2018-00206 HAS BEEN FILED FOR THE SAME EVENT FOR ALLERGEN E87 WHICH HAS DIFFERENT 510(K) # OF K021206.

    Description of Event or Problem · 1

    DISCORDANT, FALSE NEGATIVE 3GALLERGY SPECIFIC IGE RESULT FOR RAT EPITHELIUM ALLERGEN (E73) (510 (K) # K013134) WAS OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT, WHILE USING AN UNKNOWN KIT LOT. THE SAMPLE WAS ALSO TESTED NEGATIVE FOR RAT ALLERGEN (E87) (510 (K) # K021206). THE SAMPLE WAS REPEATED ON AN ALTERNATE PLATFORM FOR ALLERGENS E87 AND E73, RESULTING POSITIVE. IT IS UNKNOWN WHICH RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT 3GALLERGY SPECIFIC IGE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377370 IMMULITE 2000 3GALLERGY SPECIFIC IGE IMMULITE 2000 3GALLERGY SPECIFIC IGE DHB SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 3GALLERGY SPECIFIC IGE 601 00630414959788

    Patients

    Seq Age Sex Outcome Treatment
    1