BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT SYPHILIS TP

    MDR report key: 8773581 · Received July 9, 2019

    Report

    Report Number
    3002809144-2019-00417
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Report Date
    September 10, 2019
    Manufacturer
    ABBOTT GERMANY
    Product Code
    MTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED FOR THE CUSTOMER ISSUE AND INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF TRACKING AND TRENDING DATA, REVIEW OF THE PERFORMANCE OF THE LIKELY CAUSE, AND A REVIEW OF PRODUCT LABELING. TICKET SEARCHES FOR THE LIKELY CAUSE LOT COULD NOT BE PERFORMED SINCE LIKELY CAUSE LOT IS UNKNOWN. THE TRACKING AND TRENDING REPORT REVIEW DID NOT IDENTIFY ANY TRENDS. THE PERFORMANCE OF THE LIKELY CAUSE LIST NUMBER WAS INVESTIGATED AND DID NOT IDENTIFY ANY NON-CONFORMANCES AND/OR DEVIATIONS RELATED TO THE COMPLAINT ISSUE. A SYSTEMIC ISSUE WAS NOT IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08D06-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8D06-31 / 41. 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 REPORTED A (B)(6) SYPHILIS TP RESULT OF (B)(6), WHEN PROCESSING ON THE ARCHITECT I2000SR. ADDITIONAL TESTING WITH RPR METHOD WAS (B)(6) AND FUJI REBIO ESPLINE WAS (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566146 ARCHITECT SYPHILIS TP SYPHILIS MTN ABBOTT GERMANY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR, LIST 03M74-01| ARCHITECT I2000SR, LIST 03M74-01| SERIAL (B)(4)| SERIAL (B)(4)