BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT SYPHILIS TP

    MDR report key: 9527284 · Received December 27, 2019

    Report

    Report Number
    3002809144-2019-01095
    Event Type
    Malfunction
    Date Received
    December 27, 2019
    Report Date
    February 12, 2020
    Manufacturer
    ABBOTT GMBH
    Product Code
    MTN
    UDI-DI
    00380740117115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF TICKETS WAS PERFORMED FOR REAGENT LOT NUMBER 05464BE00. THE TICKET SEARCH DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A RETAINED REAGENT KIT OF LOT NUMBER 05464BE00 WAS TESTED IN A SPECIFICITY SETUP, INCLUDING ADDITIONAL REPLICATES OF A SPECIFICITY PANEL. RESULTS OF THIS SETUP DID NOT IMPLICATE THAT THE PERFORMANCE REGARDING SPECIFICITY OF THE LOT IS NEGATIVELY IMPACTED AS NO FALSE REACTIVE RESULTS WERE OBTAINED. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT SYPHILIS TP ASSAY FOR LOT 05464BE00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION: NO FURTHER PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSE REACTIVE ARCHITECT (B)(6) TP RESULT AND WAS INQUIRING IF THE ASSAY HAS ANY CROSS REACTIVITY WITH RED CELL ANTIGENS. THE FOLLOWING DATA WAS PROVIDED FOR THE PATIENT IN QUESTION: INITIAL RESULT = 1.71 S/CO (REACTIVE), MHA TP = REACTIVE, RPR = NONREACTIVE. THE PATIENT IS POSITIVE FOR THE "C" ANTIGEN AND RECENTLY DELIVERED A BABY. THE NEWBORN BABY HAD A SPINAL TAP PROCEDURE TO RETRIEVE CEREBROSPINAL FLUID FOR (B)(6) TESTING: ARCHITECT (B)(6) = REACTIVE, RPR = NONREACTIVE, MHA TP = NONREACTIVE, VDRL = NONREACTIVE. THE SPINAL TAP WAS PERFORMED DUE TO THE FALSE REACTIVE ARCHITECT (B)(6) RESULTS ON THE MOTHER'S SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320421 ARCHITECT SYPHILIS TP SYPHILIS MTN ABBOTT GMBH 8D06-31 05464BE00 00380740117115

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability ARCHITECT I1000SR PROCESSING MODULE| ARCHITECT I1000SR PROCESSING MODULE| LIST 01L86-40, SERIAL (B)(4)| LIST 01L86-40, SERIAL (B)(4)