BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 978482 · Received January 14, 2008

    Report

    Report Number
    1628664-2008-00012
    Event Type
    Other
    Date Received
    January 14, 2008
    Date of Event
    November 9, 2007
    Report Date
    December 19, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC
    Product Code
    JJE
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A SAMPLE FROM A POSTPARTUM PT WAS RECEIVED FROM A HEALTHCARE CENTER AND GENERATED REPEAT REACTIVE RESULTS ON THE AXSYM AG/AB COMBO ASSAY. THE SAMPLE WAS SENT TO ANOTHER LAB FOR CONFIRMATION. THE SAMPLE WAS REACTIVE FOR THE FOLLOWING COMBO ASSAYS: UNIFORM. MUREX, AXSYM AND MUREX AG MAB (AG P24). THE PT WAS INSTRUCTED TO SUSPEND LACTATION OF HER BABY. A SECOND SAMPLE OBTAINED FORM THIS PT GENERATED NONREACTIVE RESULTS ON AXSYM AG/AB COMBO. THE FIRST SAMPLE WAS THOUGHT TO BE CONTAMINATED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM AUTOMATED IMMUNOASSAY ANAYLZER JJE ABBOTT MANUFACTURING, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR AXSYM AG/AB COMBO LIST #2G83 LOT #56238LF00