BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM DIGOXIN II REAGENT

    MDR report key: 1060025 · Received June 12, 2008

    Report

    Report Number
    2623532-2008-00013
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    December 13, 2007
    Report Date
    May 22, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.
    Product Code
    KXT
    PMA / PMN Number
    K953718
    Removal / Correction Number
    2623532-05/30/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CONDUCTED TO REVIEW CUSTOMERS COMPLAINTS REGARDING THE NEW AXSYM TDM/TRANSPLANT DISK THAT WAS RELEASED IN 2006 WHICH DID NOT CONTAIN THE DIGOXIN II ASSAY FILE. THE ROOT CAUSE WAS A PROCEDURAL ERROR TO THE DOCUMENTATION. DIGOXIN II LABELING WAS INADEQUATELY ASSESSED DURING THE ASSESSMENT OF IMPACT OF THE DESIGN CHANGE TO THE AXSYM TDM/TRANSPLANT DISK TO OTHER ASSAYS (IE DIGOXIN II). THE CUSTOMER COMMUNICATION LETTER INSTRUCTED THE CUSTOMER TO CONTINUE USING AXSYM TDM/TRANSPLANT DISK TO INSTALL THE DIGOXIN II ASSAY. THE AXSYM DIGOXIN II PACKAGE INSERT WAS REVISED IN 2008 TO ONLY LIST ASSAY DISK THAT CONTAIN THE AXSYSM DIGOXIN II ASSAY FILE. A NEW AXSYM DIGOXIN II SPECIFIC ASSAY DISK IS ANTICIPATED TO BE AVAILABLE TO AXSYM DIGOXIN II CUSTOMERS BY SEVEN MONTHS LATER. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE AXSYM DIGOXIN II REAGENT PROTOCOL DOES NOT APPEAR WHEN AXSYM TDM DISKETTE IS INSTALLED. THE AXSYM DIGOXIN II REAGENT IS NOT MENTIONED IN THE AXSYM TDM DISKETTE INSTRUCTIONS AS WELL. THE CUSTOMER INSTALLED AN OLDER DISKETTE IN ORDER TO SOLVE THE ISSUE. THERE WAS NO IMPACT TO PT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM DIGOXIN II REAGENT MEIA FOR THE MEASUREMENT OF DIGOXIN KXT ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI AXSYM ANALZER