BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEUVYSION MULTICOLOR DNA PROBE KIT

    MDR report key: 18383280 · Received December 22, 2023

    Report

    Report Number
    3005248192-2023-00327
    Event Type
    Malfunction
    Date Received
    December 22, 2023
    Date of Event
    December 18, 2023
    Report Date
    February 1, 2024
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    OYU
    UDI-DI
    00884999011717
    PMA / PMN Number
    K010288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT INCLUDED A RETAIN SAMPLE EVALUATION, QUALITY DATA REVIEW AND A COMPLAINT HISTORY REVIEW. INVESTIGATION IS SUMMARIZED AS FOLLOWS: RETAIN SAMPLE EVALUATION. THE FILE SAMPLE TESTING FOR ANEUVYSION MULTICOLOR DNA PROBE KIT (LIST 05J38-050) LOT 381911 MET ALL QUALITY SPECIFICATIONS. FILE SAMPLE EVALUATION TESTING DID NOT IDENTIFY A PRODUCT DEFICIENCY AND WAS UNABLE TO REPRODUCE THE CUSTOMER'S WEAK SIGNAL INTENSITY AND NON-SPECIFIC SIGNALS ISSUE. QUALITY DATA REVIEW DEVICE HISTORY RECORD / BATCH RECORD REVIEW: THE DEVICE HISTORY RECORDS (DHR) REVIEW FOR ANEUVYSION MULTICOLOR DNA PROBE KIT (LIST 05J38-050) LOT 381911 WAS PERFORMED. THE MANUFACTURING PACKETS WERE REVIEWED TO IDENTIFY ANY ISSUES RELATED TO THE REPORTED COMPLAINT DURING PRODUCTION OF THE LOT COMPONENTS. NO ISSUES WERE IDENTIFIED. THE PRODUCTS PASSED QUALITY SPECIFICATIONS AT THE TIME OF RELEASE. CAPA / NON-CONFORMANCE REVIEW: THE CAPA REVIEW FOR ANEUVYSION MULTICOLOR DNA PROBE KIT (LIST 05J38-050) LOT 381911 WAS PERFORMED TO IDENTIFY ANY RECORDS THAT WERE POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE SEARCH DID NOT IDENTIFY ANY RECORDS RELATED TO THE REPORTED ISSUE FOR THIS LOT NUMBER. COMPLAINT HISTORY REVIEW A LOT SPECIFIC COMPLAINT HISTORY REVIEW WAS PERFORMED TO IDENTIFY ANY SIMILAR COMPLAINTS TO THE TICKET BEING INVESTIGATED, WHICH REPORTED WEAK SIGNAL INTENSITY AND NON-SPECIFIC CEP Y SO SIGNAL WHILE USING ANEUVYSION MULTICOLOR DNA PROBE KIT (LIST 05J38-050) LOT 381911. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR ANEUVYSION MULTICOLOR DNA PROBE KIT (LIST 05J38-050) LOT 381911 WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 0

    ELEVATED COMPLAINT INVESTIGATION WILL BE INITIATED. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN CHINA USING THE ANEUVYSION MULTICOLOR DNA PROBE KIT, LIST NUMBER 05J38-050, WHICH IS THE SAME/SIMILAR TO THE ANEUVYSION MULTICOLOR DNA PROBE KIT, LIST NUMBER 05J38-010, WHICH RECEIVED FDA APPROVAL.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A SAMPLE WITH AN ABNORMAL SIGNAL WHEN USING ANEUVYSION DNA PROBE KIT. THE CUSTOMER REPORTED ON (B)(6) 2023 THAT THE CEP-Y SIGNAL IS SMALL AND HAS REGULAR DOTS. ON (B)(6) 2023, THE CUSTOMER PERFORMED KARYOTYPE ANALYSIS AND A DNA MICROARRAY WHICH GAVE A RESULT OF Y-CHROMOSOME NORMAL. THE ABNORMAL Y CHROMOSOME RESULT WAS COMMUNICATED TO THE PATIENT. THERE HAS BEEN NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2153650 ANEUVYSION MULTICOLOR DNA PROBE KIT DNA-PROBE KIT, HUMAN CHROMOSOME OYU ABBOTT MOLECULAR, INC. 381911 00884999011717

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown