BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT B12

    MDR report key: 3478848 · Received November 20, 2013

    Report

    Report Number
    3008344661-2013-00050
    Event Type
    Malfunction
    Date Received
    November 20, 2013
    Report Date
    November 1, 2013
    Manufacturer
    ABBOTT IRELAND
    Product Code
    CDD
    PMA / PMN Number
    K110579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 AN ERRATIC B12 RESULT WHILE USING THE ARCHITECT B12 ASSAY. IT IS UNCLEAR WHICH RESULT IS CORRECT. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS (REFERENCE RANGE 187-883 PG/ML). (B)(6) 2011: 239 PG/ML; (B)(6) 2013: 239 PG/ML; (B)(6) 2013: 147 PG/ML; (B)(6) 2013: 97 PG/ML. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604179 ARCHITECT B12 CDD ABBOTT IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female LN 03M74-02, SN (B)(4)| ARCHITECT I2000SR ANALYZER