BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IVANCOMYCIN

    MDR report key: 1862093 · Received October 8, 2010

    Report

    Report Number
    3002809144-2010-00019
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    ABBOTT GERMANY
    Product Code
    LEH
    PMA / PMN Number
    K072036
    Removal / Correction Number
    3002809144-9/15/10-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION FOR FIELD ACTION FA13SEP2010 DETERMINED THE ROOT CAUSE OF ARCHITECT IVANCOMYCIN (LIST NUMBER 01P30-25) FOR FALSELY ELEVATED RESULTS IS DUE TO THE TRACER DILUENT FORMULATION. THE FORMULATION DOES NOT ADEQUATELY PROTECT AGAINST SPECIMEN CONTAMINATION. THE INVESTIGATION DETERMINED, AND SUBSEQUENT VERIFICATION CONFIRMED, A CHANGE TO THE CONJUGATE DILUENT WILL CORRECT THE ISSUE RELATED TO FALSELY ELEVATED RESULTS DUE TO CONTAMINATION, AND WILL ELIMINATE THE NEED FOR CUSTOMERS TO PERFORM ADDITIONAL SAMPLE CENTRIFUGATION AS INSTRUCTED IN PRODUCT CORRECTION LETTER OF FA13SEP2010. A PRODUCT INFORMATION LETTER REGARDING THIS NEW REAGENT WAS ISSUED ON (B)(4), 2012 INFORMING EX-US CUSTOMERS THAT THE NEW REAGENT FORMULATION, LIST NUMBER 1P30-27 WILL BE AVAILABLE (B)(4), 2012. THE ADDITIONAL SAMPLE CENTRIFUGATION AS INSTRUCTED IN PRODUCT CORRECTION LETTER OF FA13SEP2010 WILL CONTINUE TO BE FOLLOWED BY US CUSTOMERS. SUBMISSION FOR THE US 510K CLEARANCE OF THE NEW PRODUCT WILL OCCUR THE (B)(4) OF 2012.

    Additional Manufacturer Narrative · 1

    (B)(4), EVALUATION, CONCLUSION: SAMPLE HANDLING IS BELIEVED TO BE A CONTRIBUTING FACTOR. ADDITIONAL REQUIREMENTS FOR CENTRIFUGATION HAVE ALSO BEEN ADDED TO THE HANDLING INSTRUCTIONS. THERE IS A POTENTIAL TO GENERATE FALSELY ELEVATED ARCHITECT IVANCOMYCIN PATIENT RESULTS DUE TO SAMPLE OR SAMPLE HANDLING ISSUES CAUSING INTERFERENCE. IN RESPONSE TO THE ISSUE A PRODUCT CORRECTION WAS INITIATED. ALL CURRENT CUSTOMERS WHO HAVE RECEIVED THE ARCHITECT IVANCOMYCIN ASSAY WERE SENT THE PRODUCT CORRECTION LETTER WITH SPECIFIC INSTRUCTIONS TO CONTINUE FOLLOWING ALL SAMPLE HANDLING INSTRUCTIONS PER THE PACKAGE INSERT AND TO FOLLOW THE ADDITIONAL CENTRIFUGATION INSTRUCTIONS INCLUDED IN THE PRODUCT CORRECTION LETTER. NEW CUSTOMERS WILL RECEIVE THE INFORMATION IN THE FORM OF A PRODUCT INFORMATION LETTER DISTRIBUTED WITH THE PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED ELEVATED VANCOMYCIN RESULTS WERE GENERATED ON THE ARCHITECT I1000SR ANALYZER. ONE PATIENT GENERATED AN INITIAL RESULT OF 48.7 UG/ML WITH REPEAT RESULTS OF 38 UG/ML. AN EVALUATION HAS IDENTIFIED A POTENTIAL FOR THE ARCHITECT VANCOMYCIN ASSAY TO GENERATE FALSELY ELEVATED RESULTS DUE TO SAMPLE OR SAMPLE HANDLING ISSUES CAUSING INTERFERENCE. IN RESPONSE TO THIS ISSUE A PRODUCT CORRECTION LETTER WAS SENT TO THE CUSTOMER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT IVANCOMYCIN FOR THE MEASUREMENT OF VANCOMYCIN IN HUMAN SERUM OR PLASMA LEH ABBOTT GERMANY

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I1000SR, 1L86-01, (B)(4)