BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM GENTAMICIN

    MDR report key: 1036541 · Received April 30, 2008

    Report

    Report Number
    2623532-2008-00011
    Event Type
    Malfunction
    Date Received
    April 30, 2008
    Date of Event
    November 5, 2007
    Report Date
    April 7, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.
    Product Code
    LCQ
    PMA / PMN Number
    K935376
    Removal / Correction Number
    2623532-11/7-07-009-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CONDUCTED FOR THE ABBOTT AXSYM AND TDX/TDXFLX GENTAMICIN REAGENTS. THE ABBOTT AXSYM AND TDX/TDXFLX GENTAMICIN REAGENTS SHARE THE SAME ANTIBODY AND TRACER STOCK CONCENTRATES. A DECREASE IN THE CALIBRATOR A-F SPAN WAS OBSERVED WITH THE TDX/TDXFLX GENTAMICIN REAGENTS RESULTING IN TDX/TDXFLX GENTAMICIN CALIBRATION FAILURES (SPAN LESS THAN MINIMUM SPAN). ALTHOUGH THERE WAS AN APPARENT DECREASE IN THE AXSYM GENTAMICIN REAGENT CALIBRATOR A-F SPAN, THIS ISSUE DID NOT RESULT IN A CALIBRATION FAILURE. NEVERTHELESS, INDIVIDUAL REPLICATES OF THE MEDIUM CONTROL LEVEL OUT OF SPECIFICATION (OOS) FLAGS WERE GENERATED DURING STABILITY FOR TWO TIME POINTS. FOR THE AXSYM GENTAMICIN REAGENT LOTS, SINCE THERE WAS A POTENTIAL THE CALIBRATOR A-F SPAN COULD RESULT IN CALIBRATION FAILURES, A DECISION WAS MADE TO REDUCE THE EXPIRATION DATE FOR THE AXSYM GENTAMICIN REAGENTS, HOWEVER, THE DATA FROM THE INVESTIGATION SUPPORTS THE AXSYM GENTAMICIN REAGENT LOTS WERE NOT IMPACTED AND PERFORMED AS EXPECTED. STABILITY TESTING MONITORED AXSYM GENTAMICIN REAGENT UNTIL THE LAST TEST POINT, WHICH WAS ONE MONTH BEYOND THE REAGENT'S EXPIRATION DATE. THE CALIBRATOR A-F SPAN DID NOT CONTINUE TO DECREASE; INSTEAD, IT INCREASED, SUPPORTING THERE WAS NOT A TRUE DECREASE IN CALIBRATOR A-F SPAN FOR THE AXSYM GENTAMICIN REAGENT. WITH RESPECT TO THE AXSYM GENTAMICIN MEDIUM CONTROL OOS RESULTS, NONE OF THE SUBSEQUENT TEST POINTS SHOWED CONTROL OOS UNTIL THE LAST TEST POINT. STATISTICAL EVAL (ASSAY CAPABILITY) ALONG WITH THESE NEW TEST POINTS SUPPORT THAT REPLICATES OF MEDIUM CONTROL OOS RESULTS WERE RELATED TO THE EXPECTED ASSAY VARIABILITY, THEREFORE, THERE WERE NO PREVENTIVE ACTIONS WARRANTED FOR THE AXSYM GENTAMICIN ASSAY.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED ABBOTT AFTER RECEIPT OF ABBOTT'S CUSTOMER LETTER REGARDING AXSYM GENTAMICIN REAGENT PERFORMANCE. THE CUSTOMER STATED THEY HAD BEEN USING THE REAGENT LOT IN QUESTION FOR QUITE A WHILE AND OBSERVED ABBOTT QUALITY CONTROLS QUICKLY DRIFTING OUT OF RANGE HIGH. THE ABBOTT CUSTOMER SERVICE REPRESENTATIVE REQUESTED THE CUSTOMER FAX CALIBRATION AND QUALITY CONTROL DATA TO ABBOTT FOR DATA REVIEW. THE CUSTOMER STATED THE ASSAY PERFORMANCE IS ACCEPTABLE AFTER CHANGING THE LOT OF AXSYM GENTAMICIN REAGENT AND THERE WAS NO IMPACT TO PT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM GENTAMICIN FOR THE QUANTITATIVE MEASUREMENT OF GENTAMICIN IN SERUM OR PLASMA LCQ ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. NA 53190Q100

    Patients

    Seq Age Sex Outcome Treatment
    1 NI AXSYM PLUS ANALYZER