BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT SYPHILIS TP REAGENT KIT

    MDR report key: 21066168 · Received January 3, 2025

    Report

    Report Number
    3002809144-2025-00002
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    December 17, 2024
    Report Date
    January 31, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LIP
    UDI-DI
    00380740161934
    PMA / PMN Number
    K153730
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8D06-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8D06-41, WITH 510K/PMA/BLA NUMBER K153730.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR THE ARCHITECT SYPHILIS TP ASSAY LOT 63516BE01 INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW AND INHOUSE TESTING OF A RETAINED KIT WITH THE COMPLAINT LOT NUMBER. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. TRENDING REVIEW DETERMINED NO TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT AND COMPLAINT ISSUE. IN-HOUSE TESTING OF REAGENT KIT LOT# 63516BE01 DETERMINED THAT THE PERFORMANCE IS NOT NEGATIVELY IMPACTED. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE CUSTOMER ISSUE. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT SYPHILIS TP REAGENT, LOT 63516BE01.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NONREACTIVE ARCHITECT SYPHILIS TP RESULT ON A PATIENT. RESULTS PROVIDED: SID (B)(6) / 3.04 S/CO (<1 S/CO IS CONSIDERED NONREACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NONREACTIVE ARCHITECT SYPHILIS TP RESULT ON A PATIENT. RESULTS PROVIDED: SID (B)(6) / 3.04 S/CO (<1 S/CO IS CONSIDERED NONREACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434308 ARCHITECT SYPHILIS TP REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM LIP ABBOTT GMBH 63516BE01 00380740161934

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2000SR INST, 03M74-02, (B)(6)| ARC I2000SR INST, 03M74-02, (B)(6)