BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7438074 · Received April 17, 2018

    Report

    Report Number
    8031673-2018-01501
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Date of Event
    November 6, 2015
    Report Date
    April 17, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA (B)(4) . DEVICE BY MANUFACTURER: ON(B)(4) 2015, A TECHNICAL SUPPORT SPECIALIST (TSS) ADDRESSED THE REPORTED EVENT WHERE THE CUSTOMER INFORMED THAT THEY HAD E2 CORRELATION FAILURE. THE ISSUE IS DISCREPANT RESULTS. UNKNOWN WHAT THE ISSUE IS WITH THIS ONE PATIENT. REQUESTED SAMPLE BE SENT TO QA BUT WAS NEVER RECEIVED. THIS ISSUE IS UNRESOLVED. NO FURTHER ACTION REQUIRED. THE PROBABLE CAUSE OF THE EVENT WAS UNKNOWN.

    Description of Event or Problem · 0

    ON (B)(6) 2015, A CUSTOMER REPORTED FAILED CORRELATION E2 RESULTS WITH THEIR AIA-360 ANALYZER. CUSTOMER INDICATED A CONCERN OF TOSOH 170; REF <12. SENT TO MAYO AND THEY GOT <10. EXPECTED LOW RESULT BECAUSE THE PATIENT WAS BEING TREATED WITH LUPRON TO GET RID OF FOLLICLES. SO WHEN THEY STIMULATE HER IT WILL BE INDICATIVE OF REAL LEVEL OF E2. SHE IS TRYING TO GET PREGNANT. THEY USED AN ANTIBODY BLOCKING TUBE AND GOT 140 SO NOT MUCH DROP. CUSTOMER SENT LIST OF OTHER DRUGS SHE IS ON. LUPRON USUALLY USED IN MEN TO TREAT PROSTATE CANCER OR IN WOMEN TO TREAT OVARIAN CANCER. OVERSTIMULATES HORMONE SO THAT IT SHUTS DOWN. MEDS THE PATIENT IS ON: MEDICATIONS ON (B)(6) 2015: CHOLECALCIFEROL (VITAMIN D) 1000 UNITS BY MOUTH TWICE DAILY; NORETHINDRONE-MESTRANOL 1MG/50MCG ONCE DAILY; PRENATAL VITAMIN ONCE DAILY. GOOGLED NORTHINDRONE-MESTRANOL: "THIS COMBINATION HORMONE MEDICATION IS USED TO PREVENT PREGNANCY. IT CONTAINS 2 HORMONES: A PROGESTIN AND AN ESTROGEN. IT WORKS MAINLY BY PREVENTING THE RELEASE OF AN EGG (OVULATION) DURING YOUR MENSTRUAL CYCLE. IT ALSO MAKES VAGINAL FLUID THICKER TO HELP PREVENT SPERM FROM REACHING AN EGG (FERTILIZATION) AND CHANGES THE LINING OF THE UTERUS (WOMB) TO PREVENT ATTACHMENT OF A FERTILIZED EGG. IF A FERTILIZED EGG DOES NOT ATTACH TO THE UTERUS, IT PASSES OUT OF THE BODY. IT IS VERY IMPORTANT TO CONTINUE TAKING THIS MEDICATION EXACTLY AS PRESCRIBED BY YOUR DOCTOR. WITH CERTAIN BRANDS OF BIRTH CONTROL PILLS, THE AMOUNT OF ESTROGEN AND PROGESTIN IN EACH ACTIVE TABLET WILL VARY AT DIFFERENT TIMES IN THE CYCLE. THEREFORE, IT IS VERY IMPORTANT THAT YOU FOLLOW THE PACKAGE INSTRUCTIONS TO FIND THE FIRST TABLET, START WITH THE FIRST TABLET IN THE PACK, AND TAKE THEM IN THE CORRECT ORDER. DO NOT SKIP ANY DOSES. PREGNANCY IS MORE LIKELY IF YOU MISS PILLS, START A NEW PACK LATE, OR TAKE YOUR PILL AT A DIFFERENT TIME OF THE DAY THAN USUAL. VOMITING OR DIARRHEA CAN PREVENT YOUR BIRTH CONTROL PILLS FROM WORKING WELL. IF YOU HAVE VOMITING OR DIARRHEA, YOU MAY NEED TO USE A BACK-UP BIRTH CONTROL METHOD (SUCH AS CONDOMS, SPERMICIDE). FOLLOW THE DIRECTIONS IN THE PATIENT INFORMATION LEAFLET AND CHECK WITH YOUR DOCTOR OR PHARMACIST FOR MORE DETAILS. TAKING THIS MEDICATION AFTER YOUR EVENING MEAL OR AT BEDTIME MAY HELP IF YOU HAVE STOMACH UPSET OR NAUSEA WITH THE MEDICATION. YOU MAY CHOOSE TO TAKE THIS MEDICATION AT ANOTHER TIME OF DAY THAT IS EASIER FOR YOU TO REMEMBER. NO MATTER WHAT DOSING SCHEDULE YOU USE, IT IS VERY IMPORTANT THAT YOU TAKE THIS MEDICATION AT THE SAME TIME EACH DAY, 24 HOURS APART. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS." THE CUSTOMER IS UNABLE TO RUN E2 PATIENT SAMPLES. A TECHNICAL SUPPORT SPECIALIST (TSS) ADDRESSED THE REPORTED EVENT OF DISCREPANT RESULTS, WHICH RESULTED IN DELAYED REPORTING E2 PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279907 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1 Other