BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMMUNOCAP

    MDR report key: 20685965 · Received November 14, 2024

    Report

    Report Number
    3004973408-2024-00001
    Event Type
    Injury
    Date Received
    November 14, 2024
    Report Date
    October 31, 2024
    Manufacturer
    PHADIA AB
    Product Code
    DHB
    UDI-DI
    07333066004471
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DOCTOR/LAB DIRECTOR ATTRIBUTED THE REACTION AS BEING SPECIFIC TO THESE TWO ALLERGENS. THE DOCTOR/LAB DIRECTOR INDICATED THAT THE PATIENT DID NOT SUFFER ANY SERIOUS OR PERMANENT HEALTH CONSEQUENCES HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED BY THE DOCTOR INDICATING WHETHER THE PATIENT NEEDED TREATMENT OR MEDICAL INTERVENTION THAT WAS BEYOND WHAT WAS REQUIRED TO REVERSE THE ANAPHYLAXIS. THE STATUS OF PATIENT HEALTH HAS BEEN PROVIDED IN FOLLOW-UP TO THE COMPLAINT AS THE CHILD IS OKEY AND THE LAB DIRECTOR DOESN'T WANT TO CONSIDER THIS TO BE A RISK TO HEALTH'. PHADIA AB REQUESTED MORE INFORMATION FOR THIS SPECIFIC INCIDENT TO START AN INVESTIGATION FOR THE PRODUCTS INVOLVED IN THE INCIDENT AS WELL AS MORE INFORMATION ABOUT THE PATIENT. OCTOBER 2ND, 2024, THE US TEAM HAD A MEETING WITH THE LAB DIRECTOR THAT REPORTED THE INCIDENT. THE LAB DIRECTOR STATED THAT HE IS NOT QUESTIONING THE TEST RESULTS, BUT HE WANTED INFORMATION REGARDING IMMUNOCAP ALLERGEN F202, CASHEW NUT AND IMMUNOCAP ALLERGEN F203, PISTACHIO QUALITY TESTING. THE US TECH SUPPORT TEAM PROVIDED EXAMPLES OF COA'S (CERTIFICATES OF ANALYSIS) FOR EACH ALLERGEN, TO THE LAB DIRECTOR AND HE WAS PLEASED WITH THE INFORMATION RECEIVED. THEREFORE, IT APPEARS WHILE THERE WAS AN ANAPHYLACTIC REACTION AND RESULTS DID CHANGE FROM NEGATIVE TO POSITIVE, THE DOCTOR IS NOT QUESTIONING THE RESULTS AND JUST WANTED THE QUALITY INFORMATION FOR THE TESTS. THE US TEAM MADE MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION BUT WERE UNABLE TO OBTAIN ANY ADDITIONAL DETAILS BEYOND WHAT WAS ORIGINALLY PROVIDED. THE COMPLAINT WAS REQUESTED TO BE CLOSED DUE TO A LACK OF INFORMATION AND BECAUSE THE DOCTOR CONSIDERED THIS EVENT AS POTENTIALLY "TRIGGERED BY SOMETHING ELSE AS IT WAS DELAYED." PHADIA AB MADE AN ADDITIONAL REQUEST FOR MORE INFORMATION SINCE THE INVESTIGATION OF PRODUCTS INVOLVED COULD NOT BE PERFORMED AND STILL CONSIDERED THIS A SIGNIFICANT EVENT. ON OCTOBER 10TH, 2024, ADDITIONAL INFORMATION FROM THE US TEAM WAS PROVIDED. DURING A MEETING WITH THE DOCTOR, HE RETRACTED HIS STATEMENT THAT HE WANTED TO FILE A COMPLAINT AND THAT HE NOW JUST CONSIDERS IT AN INQUIRY. THE DOCTOR IS NOT WILLING TO PROVIDE ANY FURTHER INFORMATION ON THIS ISSUE. IN FURTHER DISCUSSION WITH THE LAB DIRECTOR, THE CAUSE OF ANAPHYLAXIS CANNOT BE ATTRIBUTED TO A SINGLE THING. THERE IS AN EXTREMELY LOW PROBABILITY THAT THE CAUSE WAS FROM PISTACHIO AS IT WAS DELAYED. THE PATIENT HAS ALLERGIES TO PEANUTS AND MAY HAVE BEEN EXPOSED. THE PRACTICING DOCTOR (UNKNOWN) HAS CLOSED THE PRACTICE AND ADDITIONAL INFORMATION IS NOT AVAILABLE. PHADIA AB MEDICAL DIRECTOR ALLERGY ASSESSMENT: TREE NUTS ARE POTENT AND FREQUENT ALLERGEN SOURCES THAT INDUCE IGE-MEDIATED FOOD ALLERGIC REACTIONS. THE PISTACHIO AND CASHEW NUTS ARE BOTANICALLY VERY CLOSE. CONSEQUENTLY, ALL PISTACHIO ALLERGICS REACT TO CASHEW AND 2/3 OF CASHEW ALLERGICS REACT TO PISTACHIO. THE PATIENT IN THIS CASE WAS TESTED NEGATIVE FOR PISTACHIO AND CASHEW IN (B)(6) 2024 AND EXPERIENCED AN ANAPHYLACTIC REACTION. IT IS UNCLEAR IF THE PATIENT REACTED TO ANY OF THE TWO NUTS. THE PATIENT WAS RETESTED IN (B)(6) 2024 AND WAS FOUND TO BE IGE POSITIVE TO THE TWO NUTS. SINCE IT IS NOT KNOWN WHAT THE OFFENDING ALLERGEN WAS, IT IS DIFFICULT TO STATE THAT THE TESTS HAD ANY ROLE TO PLAY IN THE ANAPHYLACTIC REACTION. IF THE ANAPHYLACTIC REACTION WAS DUE TO PISTACHIO/CASHEW INTAKE, IT IS LIKELY THAT BOTH TESTS WERE REPORTED FALSELY NEGATIVE. TESTS CARRIED OUT ON A SINGLE PATIENT AT DIFFERENT TIME POINTS ON TWO DIFFERENT PRODUCTS (IMMUNOCAP ALLERGEN F202, CASHEW NUT AND IMMUNOCAP ALLERGEN F203, PISTACHIO) PRODUCED NEGATIVE RESULTS ON INITIAL TESTS FOR BOTH PRODUCTS AND POSITIVE RESULTS ON SUBSEQUENT TESTS FOR BOTH PRODUCTS. THE SIMILARITY BETWEEN THE TWO NUTS MEANS THAT THE SAME RESULT ON BOTH IMMUNOCAP ALLERGEN F202, CASHEW NUT AND IMMUNOCAP ALLERGEN F203, PISTACHIO IS NOT UNUSUAL HOWEVER THERE IS A DISCREPANCY BETWEEN THE INITIAL AND THE SUBSEQUENT TEST RESULTS FOR BOTH PRODUCTS. IT IS POSSIBLE THAT THE TEST RESULTS WERE BOTH CORRECT AND THE PATIENT IMMUNE STATUS CHANGED BETWEEN THE TESTS BEING TAKEN. HOWEVER, IT IS ALSO POSSIBLE THAT AN ISSUE OCCURRED AT SOME POINT RESULTING IN THE DISCREPANT RESULTS. THIS COULD POTENTIALLY BE DUE TO SEVERAL REASONS INCLUDING A PRODUCT OR INSTRUMENT MALFUNCTION OR A USER ERROR. PHADIA AB HAS BEEN UNABLE TO OBTAIN BATCH INFORMATION FROM THE CUSTOMER ON WHICH BATCHES OF IMMUNOCAP ALLERGEN F202, CASHEW NUT AND IMMUNOCAP ALLERGEN F203, PISTACHIO WAS USED FOR THE TESTS, BUT A REVIEW HAS BEEN CARRIED OUT OF THE POTENTIAL BATCHES THAT COULD HAVE BEEN USED BY THE CUSTOMER IN AUGUST AND SEPTEMBER 2024 (ALL BATCHES OF IMMUNOCAP ALLERGEN F202, CASHEW NUT AND IMMUNOCAP ALLERGEN F203, PISTACHIO MANUFACTURED BETWEEN MAY 2022 AND OCTOBER 2024). NO DEVIATIONS IN THE QUALITY CONTROL WERE FOUND FOR THESE BATCHES. PHADIA AB HAS ALSO BEEN UNABLE TO OBTAIN THE LOG FILES FOR THE INSTRUMENT AND HAS THEREFORE BEEN UNABLE TO DETERMINE IF THERE WERE ANY ERRORS OR ISSUES WITH THE INSTRUMENT THAT COULD HAVE LED TO A DISCREPANCY IN THE RESULTS. THERE IS ALSO INSUFFICIENT INFORMATION TO DETERMINE IF A USER ERROR SUCH AS A PROCESSING ERROR OR SAMPLE MIX UP MAY HAVE OCCURRED. PHADIA AB HAS MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER HOWEVER HAS BEEN UNABLE TO OBTAIN ANYTHING FURTHER, THEREFORE DUE TO A LACK OF SUFFICIENT INFORMATION PHADIA AB HAS BEEN UNABLE TO DETERMINE THE ROOT CAUSE FOR THE DISCREPANCY BETWEEN THE INITIAL AND SUBSEQUENT TEST RESULTS. WITH THE CURRENT INFORMATION PROVIDED BY THE DOCTOR AND THE US TEAM, THERE IS NO INDICATION OF A CORRELATION BETWEEN OUR PRODUCTS AND THE ANAPHYLACTIC REACTION, BUT IT CANNOT BE RULED OUT.

    Description of Event or Problem · 0

    (B)(6) REPORTED A PATIENT (CHILD) OF UNKNOWN AGE HAD AN ANAPHYLACTIC REACTION AFTER PREVIOUSLY TESTING NEGATIVE FOR IMMUNOCAP ALLERGEN F202, CASHEW NUT AND IMMUNOCAP ALLERGEN F203, PISTACHIO. A RETEST, AFTER ANAPHYLAXIS, FOR IMMUNOCAP ALLERGEN F202, CASHEW NUT AND IMMUNOCAP ALLERGEN F203, PISTACHIO WAS PERFORMED WITH POSITIVE RESULTS. THE PATIENT WAS TESTED USING IMMUNOCAP ALLERGEN F202, CASHEW NUT AND IMMUNOCAP ALLERGEN F203, PISTACHIO IN (B)(6) 2024 WITH NEGATIVE RESULTS. THE PATIENT THEN HAD AN ANAPHYLACTIC REACTION AND WAS RETESTED ON (B)(6) 2024, WHICH RESULTED IN POSITIVE RESULTS (IMMUNOCAP ALLERGEN F202, CASHEW NUT 0.84 KU/L AND IMMUNOCAP ALLERGEN F203, PISTACHIO 5.16 KU/L).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196578 IMMUNOCAP F202 CASHEW NUT AND F203 PISTACHIO DHB PHADIA AB F202, F203 UNKNOWN 07333066004471

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male Other