BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT AUSAB

    MDR report key: 8343928 · Received February 15, 2019

    Report

    Report Number
    3008344661-2019-00015
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Date of Event
    January 26, 2019
    Report Date
    March 15, 2019
    Manufacturer
    ABBOTT IRELAND
    Product Code
    LOM
    UDI-DI
    00380740115364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM: ARCHITECT AUSAB, LIST NUMBER 01L82-27, AND MANUFACTURING SITE: ABBOTT IRELAND, DIAGNOSTICS DIVISION, FINISKLIN BUSINESS PARK, SLIGO NA, IRL, MAILTO: (B)(6), THIS REPORT TO: ARCHITECT I1000SR ANALYZER, LIST NUMBER 01L86-01, AND MANUFACTURING SITE OF ABBOTT MANUFACTURING INC, 1921 HURD DRIVE, IRVING, TX 75038, USA. MDR NUMBER 1628664-2019-00211 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETE INFORMATION FOR PATIENT INFORMATION, PATIENT IDENTIFIER: MULTIPLE = (B)(6). THERE IS NO FURTHER PATIENT INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED (B)(6) ARCHITECT (B)(6) RESULTS ON FIVE PATIENTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2019 (B)(6); ON (B)(6); ON (B)(6). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138682 ARCHITECT AUSAB ANTI-HBS LOM ABBOTT IRELAND 90007FN00 00380740115364

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR ANALYZER, LN 01L86-01| ARCHITECT I1000SR ANALYZER, LN 01L86-01| SERIAL # I1SR04089| SERIAL # I1SR04089